FirefoxIGMP runs best on - InstantGMP, Inc. · 2020-06-04 · InstantGMP MES/VAPE/PRO/INV/MD is a database application designed to manage GMP manufacturing of any FDA regulated product

Title: CSVP – InstantGMP™ User Manual-3.004.001

Document No: CSVP-UM-IGMP-3.004.001

Effective upon last signature date

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InstantGMP User Manual

Note: IGMP runs best on Firefox:

Note: see end of document for recent release notes, version history, and signature block. Table of Contents

Table of Contents ............................................................................................................................ 1 User Manual Summary ................................................................................................................... 2 Overview of Main Menu and Sub-menu choices ........................................................................... 4 Abbreviations .................................................................................................................................. 8 Definition Glossary ......................................................................................................................... 9 Icon Glossary ................................................................................................................................ 12 Manufacturing Process Overview ................................................................................................. 19 Starting a New Project ................................................................... Error! Bookmark not defined. Set-Up ........................................................................................................................................... 21

Adding Personnel ...................................................................................................................... 21 Vendors ..................................................................................................................................... 25 Material Types .......................................................................................................................... 27 Material Status .......................................................................................................................... 30 Storage Condition ..................................................................................................................... 31 Unit ........................................................................................................................................... 32 Facility ...................................................................................................................................... 33 Room ......................................................................................................................................... 34 Bin Location.............................................................................................................................. 35 Equipment ................................................................................................................................. 36 Tests .......................................................................................................................................... 37 Methods..................................................................................................................................... 37 Countries ................................................................................................................................... 38

Material ......................................................................................................................................... 41 Material Specifications ................................................................................................................. 45 Creating a Project .......................................................................................................................... 52

Project Definition ...................................................................................................................... 52 Requisitions................................................................................................................................... 61 Inventory ....................................................................................................................................... 65

Material Receipt ........................................................................................................................ 65 Inventory Status ........................................................................................................................ 69 Inventory Management ............................................................................................................. 71 Inventory Location .................................................................................................................... 73 Depleted Inventory.................................................................................................................... 74

Master Batch Records ................................................................................................................... 79

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Master Record Cover Page ....................................................................................................... 83 Master Record: Bill of Materials .............................................................................................. 85 Master Record Equipment ........................................................................................................ 88 Master Records In-Process Tests .............................................................................................. 89 Master Production Record Manufacturing Instructions ............................................................ 90 Master Record: MPR Approvals ............................................................................................... 98 Batch Production Cover Page ................................................................................................. 102 Batch Record Manufacturing Instructions .............................................................................. 107 Batch Record Approval........................................................................................................... 114

Audit Log .................................................................................................................................... 117 Reports ........................................................................................................................................ 120 Barcode ....................................................................................................................................... 122 Advanced Topics: Hiding Materials ........................................................................................... 134 Special Functions ........................................................................................................................ 136

Preparation for automated weight recording ........................................................................... 136 Serial Interface App ................................................................................................................ 138 Scan and Get Weight during batch manufacturing ................................................................. 138

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User Manual Summary This user manual is set up to use Process Flow Diagrams and a training exercise to illustrate the functions and business rules of the InstantGMP™ applications. The training exercise will lead you through the procedures and data entry steps that will allow for the production of a batch of encapsulated powder.

InstantGMP MES/VAPE/PRO/INV/MD is a database application designed to manage GMP manufacturing of any FDA regulated product. It includes entry screens for documenting personnel information, room activity and equipment histories, project and vendor information, raw materials and test specifications, purchase orders and inventory tracking as well as Master Production Records and Batch Production Records. InstantGMP runs on PCs and Macs as well as Windows based tablets (Full version of windows not RT) and iOS.




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Metascreen, collapsible areas Login screen:




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Double arrows indicate where main frame items may be temporarily collapsed out of view.

Overview of Main Menu and Sub-menu choices There are 10 Main Menu choices that reside at the left of the opening screen for the MES/PRO products. Each of them have additional sub-menus choices. Note: Access to menu items is role-specific. Note: INV and other customized workflow products may have other configurations.. The following main menu choices are found to the left of the main application screen. They contain selectable sub-menu choices in which to enter in data.

1. Setup 2. Materials




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3. Specifications 4. Requisitions 5. Inventory 6. Logs 7. Project 8. Batch Record 9. Audit 10. Reports

Sub-menus (signified by bold grey text e.g. Set-Up Personnel:) The main menu choices have sub-menus from which to choose in order to complete various activities. For example, Set-Up consists of sub-menus that open data tables and allow users to add dat to the tables. The Personnel table contains the names and contact information of personnel. The Vendor table contains the names and contact information of various material vendors.




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*Summary screens include a button for exporting data to excel at the bottom of the page.

1. Set Up

a) Personnel* b) Vendor * c) Client * d) Material Type (raw materials, components, WIP, Finished Goods, etc.) e) Material Status (Approved, Quarantine, Rejected) f) Storage Condition g) Unit h) Facility i) Room* j) Bin Location* k) Equipment Type l) Equipment m) Tests n) Methods o) Countries p) Inventory Import

2. Materials * (including Finished Goods, WIP, and Raw Materials) Material classification allows for choice of material classification and routes to correct workflow with tailored data entry screens. 3. Specifications*

a) Add Material Specifications b) View Material Specifications

4. Requisitions* 5. Inventory

a) Pending Receipt* c) Inventory Management* d) Depleted Inventory*

6. Logs (use, cleaning, maintenance)

a) Room Log b) Equipment Log 7. Project

a) Project Definition (Project & Product information) b) WIP/FG material list




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c) Project (Client Information) d) Project Personnel

8. Batch Record a) Master Production Record* b) Batch Production Record*

9. Audit

a) Audit Log b) Audit Attribute

10. Reports a. Current inventory b. Inventory Value c. Low Inventory Levels d. Production Lot Traceability e. Vendor Lot Traceability

There is a set workflow inherent to the program so that the GMP checks and balances can be carried out in real time; thus there is an order in which the training and test scripts must be executed for success. The order generally follows the menu items from top to bottom. Your trainer has access to the DBADM (database administrator) dashboard whereby s/he can toggle on and off certain features.

• Specifications may be turned off (Note: this feature is not meant to be turned on and off repeatedly)

• Inventory checks for Material amounts can be turned off • Date format may be toggeld from USA to EU • Upload your company logo/company name to be displayed • Adjust user limit • QB data transfer tool on • Allowance of FG/WIP to be added as ingredients to BOM • Scanner integration on • Automatically print labels upon material receipt • Allow same person approval for performer and verifier • Upload protocols for equipment integration (e.g. scales)

Allowance for same user to sign for logs and batch record operator/performer and verifier for those not ready for full adherence to GMPs.




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Abbreviations

Acronym Definition

ADM (Logistically temporary) Role assigned to one personnel/user in the system that has access to personnel screens to begin entering users into the system.

BOM Bill of Materials

BPR Batch Production Record

CoA Certificate of Analysis

FG Finished Good

ID Identification

INV Inventory Manager role

IO Inventory Operator role

IT Information Technology

MPR Master Production Record

MSDS Material Safety Data Sheets

oWIP Outgoing Work In Process

PM Project Manager

PS Production Supervisor

QM Quality Manager

QO Quality Operator role

Req Requisition, Purchase Order (with no associated cost )

WIP Work in Process




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Definition Glossary Acceptance Limit: result requirement for passing test. Administrator/ADM: the personnel with only personnel screen permissions in the system in order to get the User names into the system. This “user” has no signature rights and actions performed are not logged with a user name/ID, only “ADM.” Approval: Formal permission or sanction needed: signature. Approved: Confirmed or sanctioned formally, by signature. For materials and products: passed all specifications and is fit for use, distribution or sale. Bin Location: location of materials as uniquely defined by further organization than room #/name. Batch size: Amount of a finished batch, to be associated with corresponding unit. BPR: Batch Production Record; the unique and numbered documentation of the manufacture of a specific production run or batch of product. The BPR will have a unique auto-assigned batch (production or lot) number and the capture of weights, times, and other results will be specific to one instance of following the included instructions. There is an option to enter legacy production numbers as well. Client: the person or company who is responsible for funding the project. Close: close the web page without saving changes. Company: Your firm, plant, or company name (as editable on the DBADM dashboard only; this is displayed in the upper right hand corner of the application) Conditional Approval: Confirmed or sanctioned formally, by signature, but with restrictions; permission to use at risk but not to ship, or pending some specified action. Confirm: close the web page with changes saved. Data Import spreadsheet: a specially formatted spreadsheet for entry of material and FG names, vendors, material types, amount on hand, etc. for one time import that signifies an important step in implementation of IGMP in your facility/company. Note: care should be taken to ensure this data is correct and current as most data cannot be changed.




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DBADM: Data Base Administrator; role in InstantGMP utilized by InstantGMP support specialist to provide customer service and for QA tester to perform U/FAT/OP/OQ testing. Dynamic Fields: customizable field labels defined at the MPR level that can be displayed for interactive data entry or used in formulas at the BPR level; labels for interactive drop down box choices displayed at the BPR level. Equipment Integration: protocol and possibly customized screens that allow for equipment to be integrated with the IGMP system and transfer data and/or commands in one or both directions for streamlined workflows and less human transcription error. Formulation ID: number or name identifying the specific recipe, formula, instructions, product strength, flavor, unit, etc. of a product. In-Process Test: Testing or inspection of any ingredients or components of a product or WIP during any production phase. Instance: Customer-specific, secure, cloud-based Database of InstantGMP. Instance Owner: the company who has been assigned a specific instance of the InstantGMP data base and who has control of the personnel, materials, facilities, equipment, projects, logs, specifications, inventory, batch records and security settings for that specific instance. Insert: to add new record. Internet of Things: remote connectivity of processing machines with user interfaces (computers and software), servers, and hardware such as manufacturing equipment. Inventory Manager: Role specifically for those who purchase the Inventory version of IGMP with modified permissions to exclude Projects, masters and batch records and includes more rights than an operator. (similar to a PM with QM rights for material handling) Inventory Operator: Role specifically for those who purchase the Inventory version of IGMP with modified permissions to exclude Projects, masters and batch records and includes more rights than an operator. Material: any component, excipient, reagent, active ingredient or drug product that is needed for or manufactured by InstantGMP. Material Type: The Physical form of a material. MPR: Master Production Record, A written template for the recipe and manufacturing instruction steps and other info necessary for completing manufacture product.




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Operator: the personnel who use InstantGMP to perform warehouse and production activities. Order: drop down which allows users to order the results of a summary screen by any column header. oWIP : Outgoing work in process: Partially processed material that is either held for further processing, sold to a middleman or distributor, etc. treated like a finished good in inventory after processing if added to inv via the button on batch record. Performer: User/operator who completed task. Personnel: Interchangeable with user, person assigned a name and password in the application. Print: provide a hard copy or PDF copy. Product Name: product to be produced, and for which to write an MPR. Production Supervisor: the personnel role subordinate to Project Manager who is responsible for overseeing InstantGMP production at the manufacturing site. Defined in the project by the concatenation of the material name, strength, primary container and suffix. Project: (MES only) precursor to creating an MPR, assigning a WIP or FG part number with additional titles and associating with a client (differentiate the client/sponsors’ MPRs from other projects.) Project Manager: the personnel who have the InstantGMP responsibilities defined in the Project Initiation SOP. They are generally in charge of the project team and administration for manufacturing projects. Production Supervisor: Operations manager at the floor level responsible for Production Operators and Operations including log responsibilities. Quality Manager: the personnel who have the InstantGMP responsibilities defined in the Quality Management SOP. They are generally responsible for quality oversight and approval of quality operations in manufacturing projects. Quality Operator: Role allowing for more permissions than an operator for Quality control analysts. Quarantine: Isolate or put on hold; not for use until further notice, the status all received and batch-created materials default to in InstantGMP. Rejected: Not accepted, not allowed to be used.




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Requisition: request/order for materials from vendors. Save: to retain. Screen/page name: Developer chosen screen names visible at bottom left of each screen. This differs from the title of the screen which appears across the top left of each screen in large blue lettering. Specification: Set of parameters defining the tests and limits required for acceptance of a material for use in production or for distribution or sale. Status: Standard state of Quality of a component, excipient, API, raw material, WIP or finished Product; used to assess a material’s safety and conformance to applicable specifications. Standards are Quarantine, Approved, and Rejected. System Type: Status of a material, FG, oWIP, WIP, Raw. Test: name of the test or goal of a procedure. Test Method: Description of how a specific test is performed, standard to follow. Theoretical yield: Amount of product that could theoretically be produced from a recipe in the MPR given no loss (via deviations, testing/samples, QA inspection rejects, normal operation loss e.g. lost in air, residue on equipment, batch does not fill full integer of containers, etc.) Title: User Functional Screen Title visible in Blue font in top left of screen. Update: to modify a record; add, edit or delete. User: The individual with a user ID and password. Verifier: Personnel to sign for verification of a manufacturing step which a performer has completed. Verify: to confirm the truth or correctness of (something). iWIP: Work in process; incoming goods that will be used as ingredients in manufacturing. Icon Glossary




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User Name and Role: A drop down in the upper right hand corner of the screen that lists the roles that are currently assigned which user may toggle between. Note: This feature is for convenience and special circumstances and should be used responsibly and only within the scope of 21CFR part 11.

Title: At the top of the page the screen name indicates what kind of data the system will display in the current screen In the example, the title says "MPR Record Definition" Direct Access Icons: At the upper-right part of the screen there are, depending on user rights, three active icons:

o Password (change password)

o Reset preferences

o Favorite

o Home button (resets to see entire menu)

o Security (change user rights to the current screen – DBADM only) , and

o Logout (leave the application)

Pagination Buttons: The information in the table/grid is displayed in groups of usually 50 records. To access the next 50, there are paging buttons at the bottom right of the screen:

The "First" button: , the "Previous" button: , the "Next" button: and the “Last"

button to access the chosen number of records.




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The Qty of rows field allows users to adjust the amount of rows displayed on the screen. Enter

the number desired and select the icon. In some cases there may be an “Add New Record” button, which sends to a transaction screen where users can add new records.

The Confirm button registers the entered data into the data base. The Close button closes the screen and returns the user to the previous screen but does not save any changes in the database.

The Search button searches for the entered data. The Clear button clears all data from the search function and resets the screen to include all data.

The print button appears on several pages and allows the user to print an MPR or BPR.

A report for Material Specifications can be printed using the report button.

The “Copy Manufacturing Steps From Another MPR” button allows the user to select from a list of MPRs from which to import the manufacturing steps.

The “Copy Materials From Another MPR” button allows the user to select from a list of MPRs from which to import the materials.

The “Copy Equipment From Another MPR” button allows the user to select from a list of MPRs from which to import the equipment.




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The “Copy Tests From Another MPR” button allows the user to select from a list of MPRs from which to import the tests.

The update button allows certain roles to update records

The expoert to excel button allows data to be exported where it can be manipulated as necessary.

The sort/filter selector: In the right collapsible search panel there will be an option to organize the data on the grid. This drop down box allows determining how the results will be sorted/filtered. The default for these is All/largest scope.

The Show selector is available in the search panel on select screens and filters for and shows only records that fall under the selected status. The default is All.

Search /Clear: allows the user to search for records or to clear the current filters. There are several possible scenarios regarding the use of the filters: o If the user needs to find a particular record, s/he types the record name and clicks

search. o If the user does not enter anything at all in the field, then the system will display all

available data, with a default of 50 records per page. o If the user does not remember the complete record name, s/he can enter any part of it

and the system will search for all records which include the typed string. o If there is more than one filter and the user enters data in more than one field, the

system will search information that matches ALL filters entered. The Show drop down: shows only records with status of chosen option The Data Grid: The area where data is displayed. In each line of the grid there may be

two or three controls: o A hyperlink, indicated by blue text, which takes the user to the record detail.




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o Hide allows for items to be hidden once confirmed.

o An Update pen Icon ( ) which allows the user to modify the record. o In some cases there may be a version hyperlink; such as for a material or requisition

which will also be indicated by blue numbers. E.g.: Version: 2.

o The Copy (MPR versioning) icon can be seen on the MPR summary page and makes a new, editable copy of the closed-out record.

o The version up icon allows user to make a sequentially numbered version of the chosen MPR and can make changes to certain fields.

o The Scale up icon allows users to scale up the theoretical yield which automatically scales up the BOM. If the auto populate button is checked, the scaled up amounts are also transferred to the material action associated with the use of a material on manufacturing instruction steps. Note: The min and max are not automatically updated and should be checked.

o The create BPR icon allows users to create a BPR directly from the MPR summary screen.

o User-selected data lists will include the choice to update or delete an item. The delete icon will either instantly delete the record to bring up a pop-up screen asking user to confirm the deletion. Select embedded tables have gray x’s for delete buttons.

o A printer icon to the left of completed records can be selected to print specific records.

o The roles icon in the project under personnel tab allows certain user roles to access adding secondary roles for users on projects.

o Within an MPR there is the option to add dynamic fields to a manufacturing instruction step via icon.

Data Entry “T” Screens All mandatory data fileds are denoted by and asterisk. “*”

The “Choose File” button allows the user to search for documents on his or her computer to attach to a record. The attachment file Document Name link is available on the records once a file has been attached. Selecting the hyperlink of the file name will prompt pop-up box for user to choose what to do with selected file.




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The Add Test button adds a line for tests methods and acceptance limits on the specifications screen.

o Some screens will also include a material upload arrow which prompts a selection list of materials to choose from as a separate pop-up screen. This icon can be seen on MPR and BPR BOM pages, Project Definition, Manufacturing instruction Step, and Requisition screens. These screens are data entry screens whose screen names always begin with “T (for transaction).”

o Blank checkboxes are available on several screens and indicate that they can be selected; for example:

Note that some checks (gray circles with gray checks) are visible from other screens, but they can only be modified via screens whose names start with “T.” For example, the HWWMaterialStatus screen shows a list of checkboxes whose statuses can only be changed on the TMaterialStatus page after selecting the update pen icon.

The attachment file selection button appears on the Material receipt screen, Material status screen, MPR and BPR cover pages as well as the manufacturing instructions of the MPR and BPR; It allows for the attachment of a word, excel, jpg, or PDF file and is updatable (exceptions to update: after MPR is locked, after receipt has been signed off and confirmed.) This button will allow the user to open existing attachments on material status, material use, material (bin) location, and MPR and BPR covers.




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The calendar icon allows the user to select a date from the calendar rather than write it out. Change Location button allows users to change the location of a material vendor lot # via the bin location.

Split lot button allows users to split a lot of previously received material into two separate lots.

Use material button allows users to use a material from inventory in real time.

Buttons scan to change status, scan to use, scan to change location, scan to split allow user to scan a printed barcode from the system to perform each function.

The Update button appears on certain pages to allow the user to enter or change data on an existing record.

The sign button comes in different forms and prompts the pop-up signature box. Performer, Verifier, PM, QM, Approval signatures are all variants of the “sign” button and are seen throughout the program.

The Approve button prompts for signatures when a records’ data needs to be approved.




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The Add Batch Inventory button allows the user to enter the amount of a finished batch produced so that it can be tracked in inventory.

The Inventory button begins the workflow for a user to allocate use of a material in real time during batch production via the batch record manufacturing steps or for more general purposed via the inventory module. Bin location of material can also be accessed. The scan button allows users to scan a barcoded material for real time use on the BPR instruction step.

The scan and get weight button is specific to scale integration

The download purchse orders and current inventory buttons are specific to quickbooks integration with use of the app.

Manufacturing Process Overview There are many QA checks and balances written into the program which guide an organized workflow that follows Good Manufacturing Practices:




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Create/UpdateMaster Record

Create/Update Batch Record

(Copy of Master Record)

Enter/Upate Setup

Information

Bill of Materials

Equipment

Mfg Instructions

Approvals

Bill of Materials

Equipment

Mfg Instructions

Approvals

Master RecordApproval

Login

Add Batch to Inventory

Enter Materials Create/Update Specifications

Requisition Material

Manage Inventory

Create/Update Project

Manage Room & Equipment Logs

Enter data and set up for a Master Record The checks and balances make quality a built in process that minimizes deviations and omissions.

EnterMaterial Info

Enter/UpdateSetup

Information

SpecsApproved?

Create/Update Project

System Assigns Part #s,

Enter/UpdateRM/iWiP Specs

No

ProjectManager

Personnel

Vendor

Material Types

Material Status

Unit

StorageConditions

Facility

Equiment

Room

Tests

Methods

Countries

QualityManager

Select FG/oQIP to manufacture

Select Client(s)SpecificationsApproval

Initiate/UpdateProject

ProjectManager

Create Product Name(s)

Assign Personnel and Rolesin Project

Client

SpecsApproved?

Enter/UpdateFG/oQIP Specs

No

QualityManager

SpecificationsApproval

ProjectManager

Ready to Create Master Production

Record

Bin Location

Equipment Type

Reference: SOP-101 Project Initiation Optional features: Some features within InstantGMP are controlled in the background by the DBADM dashboard. Contact your InstantGMP support specialist to toggle these features on and off:

1. QuickBooks Data Transfer tool




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2. Ability to include FG and WIPs as ingredients in a Bill of Materials on the MPR. 3. Scanner Integration 4. Automatic Printing of Label on Receipt 5. Inventory Check Off 6. Specs Off (popular for VAPE) 7. Same person allowed on dual signature (popular for VAPE) 8. Medical Device View vs. MES view 9. EU date format vs US date format

Other optional features: 10. Increase user limit (contact [email protected]) 11. Data import spreadsheet allows for import of vendor and material definitions (raw,

WIP and FG names) (visit instantgmp.com or contact support specialist for excel file with instructions.)

12. Integrate scales to import weight data directly into logs, reports and Batch Records. Begin Using Program STEP 1. Open your Instance of InstantGMP using your assigned Hyperlink to the secure

web address.

STEP 2. Sign in with your assigned UserID and password or with ADM user ID and password to create a new user.

(This information is provided by InstantGMP support via email) Set-Up Adding Personnel

STEP 3. Navigate to: Set-Up menu Personnel Through this option a user shall have the ability to insert, update and search Personnel. The password must follow a medium password strength policy.

mailto:[email protected]




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STEP 4. Select Update pen icon for ADM.

STEP 5. Enter your e-mail for ADM (mandatory).

STEP 6. Confirm.

STEP 7. Select Add New Record button to create a new record.




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STEP 8. Enter First and Last Name (Project Manager) and enter email address (mandatory)

STEP 9. Enter “pass1233” for a medium strength password (mandatory)

STEP 10. Select Project Manager role from the Default Job Function dropdown (mandatory)

STEP 11. The Administrator Rights Permission set is granted by clicking the checkbox

STEP 12. Click




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STEP 13. To add badge information click for the person and select a start date of no later than current date and an end date of a year from now. (the badge scanner option must be selected for on the dashboard for the feature to appear)

STEP 14. Repeat these steps for the Quality Manager role

Application Rules:

• First Name and Last Name are mandatory. • Email address is mandatory • Only Administrators and those with AR rights shall have the authority to grant and revoke the

Administration permissions set. Only Project Managers should be designated as users with AR rights. Project Managers should not give Administrative rights to any other roles unless the specific person is trained in the complete application and their project duties include updating administrative information.

• Anyone without the Administrator credentials is prevented from making any changes to screens that are within the Administration menu and its sub-menus.

• User ID is automatically assigned by the program with the following formula: First letter of first name First seven letters of last name Sequential number starting with 01. (if Jane Doe were to be added next, she would be

JDoe02) UserID is not case-sensitive

• A password of medium strength is required; (must include alpha and numeric characters.) • Password is case sensitive. • The default Role is mandatory. Personnel may login immediately after role assignment on this

screen. • Note: for those users created before primary role was mandatory and cannot log in: Each

userID must be assigned a Primary Job Function in order to log into the application. (Until a primary role is assigned on the TPersonnel screen, the application has no permission boundaries set for that person; the default is no permission set and the person cannot get to the main menu).

• After confirmation of the personnel screen, the option to create a badge is available on the TPersonnel screen and the option to print the badge is available on the HWW screen.




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Forgot Password function: If a user cannot log in or wants to set a new password, s/he must select the “forgot password” button on the login screen. The system will prompt for the users’ email associated with the UserID in IGMP and will mail a link to that email whereby the user can reset the password. Vendors STEP 15. Navigate to: Setup Vendor References: POL-0302 Vendor Selection and Qualification, SOP-212 Program to Qualify Vendors Users have the ability to insert, update and search for Vendors. Note: The Company added on the Dashboard is automatically auto assigned as the first Vendor and first Client. Manufacturer/repacakger/redistributor using IMGP must be listed in the vendor table. When FG or WIP materials are to be produced using InstantGMP Batch records, the vendor list is selected from to identify the vendor of that manufactured FG or WIP. Note: The company name entered on the DBADM dashboard will automatically populate as the first vendor. Note: Information other than Company Name is not mandatory and can be filled in at your leisure

STEP 16. Click

STEP 17. Enter “Training-Great Raw Materials” as a vendor.




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STEP 18. Click

Client STEP 19. Navigate to: Setup Client Note: A Client is any company ordering/funding projects, and/or represents clientele for whom your firm does manufacturing, holding, packaging or private labeling. Alternatively, your firm may be a Client who holds/packages/labels WIP/FG from other suppliers whom you are mandated by the FDA to procure MPRs and BPRs from in efforts to trace raw materials to customers and vice versa. There are different ways to set up MPRs depending on your firm’s role in the process.

STEP 20. Click

STEP 21. Enter Client Name: Training

STEP 22. Select “United States” from the Country drop down box.

STEP 23. Click




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Material Types STEP 24. Navigate to: Setup Material Types References: POL-0303 Material Control Requirements, SOP-302 Material Types

Through this option a user shall have the ability to insert, update and search Material Types.

An effective Material Control system is essential to ensure that material and components are procured, received, approved for use, labeled including expiry date, coded, stored, transported and dispensed according to documented procedures when InstantGMP™ is used.

Note: These names will be the only items available in drop down boxes when material types need to be selected and are essential to optimal organization of materials within InstantGMP.




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When new “Material Types” are entered into the system, they must be further classified with a “System Type.” This will differentiate types of materials in other screens of the application where the system type is not displayed. This will be important for searches and filters for materials in other data base tables.




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Only “oWork in Process” or “Finished Goods” material types will appear when a Part # is needed in the Project Definition screen. Material Types that have a system type of “Work in Process” or ‘Finished Goods” will not be editable. The screen does not have the “update” button available for these types.

STEP 25. Click

STEP 26. Enter “Raw Material” in the Material Type Name field

STEP 27. Select “Raw Material” from the Type drop down box

STEP 28. Click

STEP 29. Click

STEP 30. Enter “Packaging” in the Material Type Name field

STEP 31. Select Raw Material from the Type drop down box

STEP 32. Click and repeat steps for the material types that apply to your operation.




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Note: Finished Goods is a preset option and does not need to be entered; however, customization such as “Encapsulated Finished Goods” can be created for convenience. Material Status STEP 33. Navigate to: Setup Material Status References: POL-0303 Material Control Requirements, SOP-304 Material Status

Through this option a user shall have the ability to insert, update and search Material Status. Application Rules:

• The system will always maintain the material statuses "Quarantine," "Approved" and “Rejected” which cannot be deleted.

• The system will allow entry of other material statuses. Note: “Is Quarantine” is used as a default to define the status when an incoming material is first received or internally produced WIP of FG is logged into the inventory after production. • A Material Status of “Is Quarantine” prevents the material from being used in a production batch. • Only the material types in this screen will appear in drop down boxes for material approvals.

Optional: steps 29 – 36, adding customized Material Statuses.

STEP 34. Click

STEP 35. Enter “FG Retains/Stability” in the Material Status field

STEP 36. Select the “Is Quarantine” checkbox

STEP 37. Click

STEP 38. Click

STEP 39. Enter “Approved for R/D” in the Status field




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STEP 40. Check the box for “Is Approved”

STEP 41. Click

Storage Condition STEP 42. Navigate to: Setup Storage Condition Reference: SOP-412 Environmental Chambers and Storage Note: “Storage Conditions” refer to the conditions that are available in the facility covered by an instance of the data base. Only the storage conditions in this screen will appear in drop down boxes when storage conditions have to be specified.

Through this option a user has the ability to insert, update and search Storage Conditions. If there are stability chambers, cold rooms and warehouses, each condition should be entered. The Storage Condition Name is a unique and required field.

STEP 43. Click for the “Ambient” selection.

STEP 44. If your facility has specifications for ambient room temperature such as: 18 C 45%RH, or 68-73 F, 44% RH, enter it here; otherwise, make no changes.

STEP 45. Click




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Unit STEP 46. Navigate to: Setup Unit

“Unit” refers to units of measure that will be used in the purchasing and use of materials and in creating batch formulas. The unit conversion feature enables the operators to purchase material in larger quantities (e.g.: kg) and deplete the inventory in smaller quantities (e.g.: g) and vice versa if applicable. Application Rules: • Only the units in this screen will appear in drop down boxes when units have to be specified. • Additional static units may be added by selecting the insert button and confirming a new entry.

These units will not be interchangeable nor will they convert from or to any other unit. • The Unit Name is a unique and required field. (this only applies to additionally added units, which

for most companies is not necessary.)




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Facility STEP 47. Navigate to: Setup Facility Reference: SOP-404.01 Facility Start-Up and Shut-Down, SOP-401.01 Performance Qualification of Systems (PQ), SOP-402.01 Facility Access and Security, SOP-403.01 Warehouse and Production Area Cleaning and Maintenance. “Facility” refers to the buildings/Campuses where manufacturing/holding/packaging is to be tracked in a single instance of InstantGMP software system. Through this option a user has the ability to insert, update and search Facilities. System Rules:




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• Only the facilities entered on this screen will appear in drop down boxes for specifying facilities.

• The Facility Name is a unique field.

STEP 48. Click

STEP 49. Enter Facility name “Training-Manufacturing Site”

STEP 50. Click

Room STEP 51. Navigate to: Setup Room References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-406.01 Equipment and Room Logs and Status Tagging Through this option a user shall have the ability to insert, edit and search Rooms. Room refers to any numbered room or designated space used for storage/holding, processing or packaging of materials and components, as well as any spaces used to support or facilitate those functions or processes documented in InstantGMP. (e.g. weigh room, airlock, gowning room, controlled hallways, etc.) Application Rules:

• Only the rooms entered via this screen will appear in drop down boxes when rooms have to be specified.

• Every Room must be linked to a Facility. This is implemented via mandatory selection of a Facility from a drop-down box to define a room.

• Room number must be unique per facility. Room names can be used multiple times.

STEP 52. Click

STEP 53. Select “Training-Manufacturing Site” from the Facility drop down box.

STEP 54. Enter the room number 99900 and room name Z -Training




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STEP 55. Click

Bin Location STEP 56. Navigate to: Setup Bin Location References: SOP: 420 Facility Maintenance and Modifications Application Rules: Facility must be unique and is required.

STEP 57. Click STEP 58. Select “Training-Manufacturing Site” from the Facility drop down box.

STEP 59. Select “99900-Z -Training”

STEP 60. Enter “102” for Bin Number

STEP 61. Enter “Samples” for Bin Location

STEP 62. Click




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Equipment STEP 63. Navigate to: Setup Equipment References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-406.01 Equipment and Room Logs and Status Tagging

Through this option a user has the ability to insert, edit and search Equipment. The Equipment Code is a unique field entered by the user.

Application Rules: • Only the equipment in this list will appear in drop down boxes when equipment has to be specified. • Equipment name and number are mandatory

STEP 64. Click STEP 65. Enter in Equipment Number “999999” and Equipment Name “Training - Equip”

(required fields.) Add arbitrary numbers to model and serial number. Select calendar and current date for due dates.

STEP 66. Click




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Tests STEP 67. Navigate to: Setup Tests

Reference: SOP-215.00 Tests “Tests” are the titles of the attributes, quantitative or qualitative, that will be used to determine whether materials in question are in compliance with specifications. A Test names what is being tested for. Application Rules: • Through this option a user shall have the ability to insert, update and search Tests. • Only the tests entered in this screen will appear in drop down boxes when tests have to be specified. • The Test Name is a unique field.

STEP 68. Click

STEP 69. Enter “Micro”

STEP 70. Click

STEP 71. Repeat steps for more tests if applicable to your operation

Methods STEP 72. Navigate to: Setup Methods Reference: SOP-216.00 Methods Application Rules:

• “Methods” are the actual procedures that will be used when testing of materials is required to show the materials are in compliance with specifications. A method is How to test.




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• Through this option a user shall have the ability to insert, update and search Methods. • Only the methods confirmed via this screen will appear in drop down boxes when

methods have to be specified • The Method Name is a unique field.

STEP 73. Click

STEP 74. Enter Method associated with a test. “USP (62)” Note: a specific SOP #, procedure #, or Assay name could be used here as well.

STEP 75. Click

STEP 76. Repeat steps for more Methods that are applicable to your operation

Countries STEP 77. Navigate to: Setup Countries

“Countries” identify locations where manufacturing/holding/packaging/labeling facilities are located or where personnel are based. Application Rules:

• Only the countries in this screen will appear in drop down boxes when countries have to be specified.

• Through this option a user shall have the ability to insert, update and search Countries. • The Country Name is a unique and required field.

STEP 78. Click

STEP 79. Enter Country name. “UK”




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STEP 80. Click




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Material STEP 81. Navigate to: Materials

References: S308 Part # Assignment and POL-0208 Project Initiation Through this option a user has the ability to insert, update, and search Materials. “Materials” are parts and components for manufacturing or the products of manufacturing. Material Classifications separate these two types of materials for ease and organization: Incoming raw materials, components, packaging and labelling and incoming WIPs vs. Outgoing WIPs and finished Goods (in house WIP counts as outgoing since it is manufactured Note: The components, excipients, raw materials, incoming and outgoing work in processes and finished goods WIPs are materials that are either ordered for further use in production, precursors to products to be manufactured in-house or shipped to be further processed elsewhere. Example: bulk powder herbal blends are FG for the blend manufacturer but are Raw Material for the encapsulator. For the encapsulator, bulk capsules are WIP if packaging is done in-house or FG if sent to a third party. Application Rules:

• Materials should only be ordered from approved/qualified vendors; see business rules on Vendor Qualification. Note: InstantGMP and applicable SOPs assume that all materials ordered are from qualified vendors according to SOP-0212 – Program to Qualify Vendors.

• The Part Number is a read-only and auto-numbered field assigned by the application • Material Name is a unique field. An error message will be displayed if a duplicate is

entered. • Products to be manufactured are automatically assigned Part #’s by the system prior to

production so these materials can be tracked by the system prior to and after manufacturing.

• Material Classification, Material Name, Type, Unit and Storage Condition are required fields.

• The Material Name will be a read-only field after it is created. • In the Material Update screen shown below, the Material name cannot be edited. • Vendor number is akin to a catalogue number from a vendor; individual lot numbers are

entered later.




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• The application will alert user with red error messages when any mandatory field has been overlooked.

• The selected Unit for outgoing materials should represent the Material units required when creating the batch.

o Note: Take time to consider ordering unit, densities used in any calculations and unit of sale item. This is a crucial step of the organizational process that can save you consulting hours in the long run.

The search panel on the right includes a search for part #, material name, material ID and a filter for Material type.

STEP 82. Click

STEP 83. Select “Raw Material/In-Coming WIP/Other” Material Classification




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STEP 84. Click




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Note: The Product Name Wizard is now included at tmaterial page for outgoing part #s. Option for Material strength and suffix are available and are strung together in a permanent concatenation of the “Product Name” exclusive of packaging which is associated with a specification. This Product name can then be further defined at the Project level with options for strength, Primary container and suffix field that can be used for packaging, etc.

STEP 85. (Mandatory) Select the (Material Type) “Ingredient-RM” (See Figure 21)

STEP 86. (Mandatory) Enter the Material Name “Training-Raw Powder” The Strength and suffix are optional. They will be displayed as a concatenation representing the material unpackaged. This will be assigned a part number and be the root of a specification.

STEP 87. (Mandatory) Select the unit of measure associated with the material. “g”

STEP 88. Enter the Material ID “Training Raw 1”

STEP 89. Enter the Material Description “Fine white powder”

STEP 90. (Mandatory) Select Storage condition from the dropdown box. “Ambient”

STEP 91. Enter a shelf life (based on stability studies, the limiting ingredients’ expiration date or a default standard) “12 months”

STEP 92. Enter QM retest period (based on QA retain or stability test specifications) “12.000”

STEP 93. Enter a vendor order number if known (static number used from a supplier to represent that material): “TrainingGRM-1”

STEP 94. Select Vendor from the dropdown box. “Training-Great Raw Materials” (Select your own company for products produced or packaged in-house)

STEP 95. Click

STEP 96. Repeat steps 81 through 95 for “Training-Capsules” (See Figure 21)

STEP 97. Repeat steps 81 through 95 for “Training-Container” (See Figure 21)

STEP 98. Repeat steps 81 through 95 for “Finished Encapsulated Product FG” (See Figure 21)

Note: For this material’s Select Material Classification Use “Finished Good/Outgoing WIP”

Material Type Ingredient-RM Component-RM Primary Container-RM

Packaged/Labeled-FG

Material Name Training-Raw Powder

Training- Capsules

Training-Container

Finished Encapsulated Product FG




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Unit g ea ea kg Material ID Training Raw 1 Training Raw 2 Training PC Training Finish Material Description

Fine white powder Clear, no band vegetarian gel

White plastic bottle

Encapsulated Powder

Storage Condition

Ambient Ambient Ambient Ambient

Recommended Shelf Life

12 months 12 months 120 months 12 months

QM Retest Period

12 3 12 3

Vendor Order Number

TrainingGRM-1 TrainingGRM-2 TrainingHDPE

Vendor Training Great Raw Materials

Training Great Raw Materials


Figure 21 Note: Confirmation will return user to the HWWMaterial screen with a summary of all materials confirmed.

Material Specifications Specifications for Raw materials including any components, labels, etc. or incoming WIPs may be any tests completed to prove the purity, strength, identity or general physical properties and fitness for use in production. This also includes any visual comparison to a known standard as well as other organoleptic methods. Specifications for outgoing WIPs and FGs produced in-house may also have specifications for final purity and strength, retain and stability testing and in-process testing such as fill volumes or weights of capsules, pH, uniformity of color or viscosity, inspection of containers, closures, packaging and labelling, among others. STEP 99. Navigate to: Specifications

The Material Specifications page “HWWSpecification” screen shows all specifications, allowing for filtering for “Approved,” “Pending Approval” and “All.”




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Application Rules:

• The record is automatically assigned a sequential version number. • A user has the capability to insert, update and delete tests/methods/etc. for a Material

Specification until both the PM and the QA signatures are confirmed. No further changes can be made after the PM and QM approvals are confirmed.

• Part #s with an update icon indicate that the material specifications have not yet been approved and locked.

• A version 2 cannot be created until the version 1 signatures have been confirmed. (A part # whose specification is open (not locked) will not appear on the “Select Part # to version Up” screen (and a new specification version cannot be created) because the prior version has not yet been approved and is still editable.) Open records will only appear on the HWWMaterialspecification screen and can be seen by filtering for “pending approval” or “ALL”

• QM and PM approval is necessary for the Material to be used in the Bill of Materials of an MPR, inventory, or projects.

• If a material needs different specifications for different uses (e.g. lactose in a liquid product vs. lactose in a powder product), a new material part number must be created and assigned unique specifications.

• Different versions of a material specification may be used concurrently in different MPRs




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This list is comprised of materials with specifications still pending one or more signatures and materials for which specifications are completed and locked down. Note: if you expected to see records on this screen but do not, select filter in the right collapsible panel, for “ALL” to display those records.

STEP 100. Click to create new specification.




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This list is comprised of new materials without specs assigned and materials with signed off specs for which a new specification record can be generated. If a material does not appear on this list, the material has an open record that needs to be edited and/or signed. To access open records, select the “Cancel” button to return to the hub screen and filter for “Pending Approval” or “All.” Records with update arrows can be modified and signed and locked.

STEP 101. To create version 1, Click the for the “Training-Raw Powder” Material.




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Note: Even if no data is entered, confirming creation of this record will move the record to the HWWSpecifications screen for in-process records awaiting approval and shall be accessed via the update icon.

STEP 102. Enter the effective date or current date of the test specifications for the material.

STEP 103. Enter the MSDS/ Safety and Handling Data “Wear gloves and mask; handle and store in cool dry environment”

STEP 104. Enter General Sampling instructions for the material “Use plastic scoop #3 to aliquot 5 grams into each of three plastic sample jars. Secure lid and label”

STEP 105. Click Add test button

STEP 106. Select test “Micro” from drop down.

STEP 107. Select Method “USP <62>” from drop down.

STEP 108. Enter a Acceptance limit of “<0 CFU”

STEP 109. Enter a Sampling of “In Process Visual”

STEP 110. Select the box for Required for Release

Note: The box for release indicates that the test in question is required to meet specs before the material or product is released for R&D, production use, distribution or sale.

STEP 111. Click




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STEP 112. Log out

STEP 113. Login as PManager01

STEP 114. Select Signature prompt for Project Manager/Project Supervisor

STEP 115. Click

STEP 116. Log out

STEP 117. Log in as QManager01

STEP 118. Select Signature prompt for Quality Manager

STEP 119. Click

STEP 120. Repeat steps for the remaining material part #s in order to set and approve

specifications for all materials needed for production including the finished good product:

Material Name Training - Capsules Training-Container Finished Encapsulated Product FG

Effective Date Use current date Use current date Use current date Safety/Handling Don gloves, keep cool

and dry Don gloves, keep cool and dry

Don gloves, keep cool and dry

Sample Instructions Clean dry scoop/Close and label with lot#, personnel initials and date/see methods.

Clean dry scoop/Close and label with lot#, personnel initials and date/see methods.

Clean dry scoop/Close and label with lot#, personnel initials and date/see methods.

tests Select a test and method from drop down

Select a test and method from drop down

Select a test and method from drop down

STEP 121.




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Note: A New sequential version (2) may be created by clicking the version up icon for part number on the version up screen and repeating steps for a part number with an approved specification version 1. Reason for change is required. Inventory Import A formatted spreadsheet is available for download from the Import screen.

Once the spreadsheet is filled out according to instructions it can be imported via the “import materials/inventory” button.

Select “Process file” button to run an error check on the data Select close The status and messages for each data set will show in application Sign for PM and QA




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For prerequisites, rules, details and examples, see “Advanced Topic: Inventory Import” document

Creating a Project Application Rules:

• Project managers can create projects, QMs cannot confirm creation of a project or make changes (they can see the project but cannot confirm

• Your firm should be entered as a Client as well as a Vendor.Project Definition STEP 122. Navigate to: Project




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STEP 123. Click




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Application Rules:

• The Project Title is a unique and required field. • The Project Title is read only once the Project is created. • Only parts that are “oWIP” or “Finished Goods” that have signed off specifications

(unless specs are turned off) can be selected in the Part Number field. • Multiple part numbers may be selected for a single project. • Multiple products built on the same part number are allowed per project as long as

the concatenation of the material name (including strength and suffix from material page) and the primary container and any secondary optional data (strength and suffix at project level) are unique.

• Only Pms and QMs are auto assigned to a project • Signatories required for MPR/BPRs must be assigned manually

STEP 124. Enter the Project Title “Training -Finished Encapsulated Product”

STEP 125. Enter a Project description (optional)

STEP 126. Select WIP/FG Part # Tab




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STEP 127. Click




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STEP 128. Click for “Training - Finished Encapsulated Product FG”




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STEP 129. Enter Strength

STEP 130. Click for the Primary Container part # selection list




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STEP 131. Select the hyperlink for the Primary container

STEP 132. Enter a Product Name Suffix (optional)

STEP 133. Click

STEP 134. Select the Client tab

STEP 135. Add secondary client if applicable

STEP 136. Select the Personnel tab




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Note: Delete personnel from the project or add personnel to the project using

button

STEP 137. Click to add a secondary role for the PM

Application Rules: • Personnel can be assigned different roles for different projects. • Personnel can be assigned multiple roles per project. • A person can be an MPR Approver and/or a BPR Approver, or neither. • Each Project should have at least one MPR and at least one BPR approver assigned.

STEP 138. Click




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STEP 139. Select Quality Manager role from the drop down

STEP 140. Click

STEP 141. Select update icon for PManager01

STEP 142. Select the MPR and BPR checkboxes

STEP 143. Click




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Requisitions

STEP 144. Navigate to: Requisitions

Through this option a user can create a material requisition with multiple materials from the same vendor. Application Rules:

• The system will allow a user to build a requisition using materials from a single vendor. • One and only one vendor is identified per requisition • Only approved Material Specification versions will appear in selection list • The Part Number, Unit, and Qty fields are required fields for each line of the requisition. • Unit chosen must be equivalent to or convertible to the unit assigned to part # on Material

page • Amounts ordered for a material requisition can be converted to other units within that

unit system but cannot be converted from weight to volume or vice versa. • The system will assign a unique requisition number for each requisition created. • Once a Requisition is signed and confirmed it cannot be edited. The system will display a

print icon yielding a PDF version of the requisition • No update icon will be displayed when the record is no longer editable.

STEP 145. Click

STEP 146. Select the Vendor “Training-Great Raw Materials”




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STEP 147. Select needed by date (Today’s date)

STEP 148. Click

The “Select Material Specification” pop up will appear

STEP 149. Select “Training - Raw Powder” (popup is closed automatically)




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STEP 150. Enter Qty “3.010”

STEP 151. Select the unit kg from the unit drop down box.

If not already present, Enter “TrainingGRM-1” in the Vendor Order Number field. STEP 152. Make sure to check the boxes for MSDS and COA. (Material Safety Data Sheets

and Certificate of Analysis)

STEP 153. Click

Repeat steps 145 through 152 for Vegetarian Capsules as seen below:

STEP 154. Click at the bottom of the page

STEP 155. Enter credentials and confirm.

STEP 156. Click




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Vendor Material Name Unit Quantity Vendor Part Training Great Raw Materials

Training Raw Powder

kg 3.010 Training-GRM-1


Training Capsules - Vegetarian

ea 1000 Training -GRM-2


Primary container

ea 100 TrainingHDPE

STEP 157. Select the printer icon on the requisition screen.

STEP 158. Print and or email electronic copy of the Requisition Order to Project Manager. (Functionality will depend on version of Adobe)

Regardless of the accompanying software, the printout will appear as below:




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Inventory This module includes Receipt, Status update, location change, split lot and Use of material lots. Material Receipt

STEP 159. Navigate to: Inventory Pending Receipt

Application Rules: • The system shall automatically assign a unique Receipt Number for each material

requisition (or partial receipt thereof) received.




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• A digital signature is required to save a material receipt record. • The system will allow a user to record the receipt of a specified quantity of material

which is added to the inventory upon confirmation of signature. • The system will allow a user to search for a material based on either Part Number,

Receipt Number, requisition number or material name. • The system will allow a user to record inventory usage details for each receipt number in

the system. • Through this option a user can search all the material that was ordered/ready to be

received.

STEP 160. Click for a receipt to receive

STEP 161. Select the MSDS and COA checkboxes indicating that the data was received.




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STEP 162. Enter the Qty received 3.010

STEP 163. Select the unit received

STEP 164. Enter Vendor lot # “Training 2,” representing the specific lot received.

STEP 165. Select calendar icon and select today’s date for date received.

STEP 166. Select calendar icon for “Use by” date; select one year from now by selecting double arrow icon and selecting date.

STEP 167. Attach any CoAs or MSDSs via the “Choose File” buttons.

STEP 168. Click

STEP 169. Enter credentials

STEP 170. Click

STEP 171. Repeat steps for the remaining part number receipt Vegetarian Capsules.

Vegetarian Capsules Primary Container Qty Rcv 1000 100 Units ea ea Vendor Lot Number Training-GRM 2 TrainingHDPE Date Received Use current date Use current date

Use By One year from current date

One year from current date

Note: label can be printed by selecting print icon




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Application Rules:

• Qty received, date received, vendor lot number and signature are required fields • Upon confirmation of a material receipt record, that receipt# is no longer available on the

receipt screen • Upon confirmation of a material receipt, the record becomes available in the Material

Management section with a default status of “Quarantine” and on the Material use screen. Inventory Status STEP 172. Navigate to: Inventory Inventory Management

Application Rules: • Only a Quality Manager (or inventory manager in the INV system) can change the status

of received inventory. • Any updates require a digital signature and will always display the UserID/time/date

stamp from the latest confirmed update. • The default value for all materials is Quarantine.

The Inventory Status screenshot shows the record created for a material received.

STEP 173. Select the Receipt number hyperlink




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STEP 174. Logout and log back in as a QM OR toggle to the QM role in the upper right hand

corner of the application.

STEP 175. Click

STEP 176. Expand the Status drop down box and select Approved

STEP 177. Select enter credentials and confirm

STEP 178. Write “Training- All tests passed, see attachment” in the comment field

STEP 179. Select the browse button and attach a document to represent test results.




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Note: the hyperlinked file names can be selected to bring up an open/save window for the previously attached document.

STEP 180. Click

STEP 181. Repeat steps for Vegetarian Capsules and Primary Container.

Inventory Management STEP 182. Navigate to: Inventory Inventory Management

Application Rules • Once a material is received in Material Receipt, the received quantity is populated in the

Quantity Rcv field expressed in units from receipt screen. • Qty remain will be expressed in units from the Tmaterial screen • A record will be created for each Material received in Material Receipt • A quantity greater than zero must be entered.. • A user shall have the capability to remove/deduct (edit) material amount from each

Material Receipt Line with Quantity available. • The system will display the history of inventory usage records and the inventory balance

for each receipt number. • The system will allow a user to enter an inventory usage record using convertible units

(i.e.: g/mg; mL/L) and properly record the inventory balance in the default unit for that receipt.The Project Manager Can receive partial lots which can be managed separately.

• Material receipt numbers are assigned to materials added to inventory via the “add batch to inventory” button on the BPR.

STEP 183. Select the receipt number hyperlink for a part number.

STEP 184. Click




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STEP 185. Enter “1.0” in the Quantity Used field

STEP 186. Select “g” from the Unit drop down box

STEP 187. Enter “Training Exercise- Testing” in the Purpose box

STEP 188. Click

STEP 189. Enter credentials and confirm

Optional: Select gray attachment button or attach another document.

STEP 190. Click




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Inventory Location Inventory Location allows users to assign and change the location of an entire material receipt #’s vendor lot#/material/amount/unit via the bin location tied to a facility and room. STEP 191. Click receipt hyperlink for material

STEP 192. Click




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STEP 193. Select the Facility, Room and Bin Location from the drop downs

STEP 194. Sign and Confirm

Depleted Inventory STEP 195. Navigate to: Inventory Depleted Inventory

Application Rules • Materials with a 0 balance will be in this list. • lots can be editied for reconciliation/material management purposes. • Through this option a user can view, order and search all the Material Receipt lines with

no Quantity available. • The same person cannot sign for the performer/operator and the review of a log. • A QM cannot sign as the operator.

STEP 196. Navigate to: Logs Room Log

Through this option a user shall have the ability to insert, update and view the log entries of the Rooms and Equipment defined on the corresponding Administration screens.




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Note: The room name can be a number.

STEP 197. Select Room # hyperlink for Facility

STEP 198. Click Enter:

Facility Training - Manufacturing Site Room Name Z - Training Activity Room Cleaning Cleaning Agent, Lot # Alcohol solution, Lot #222 Prod Name or Part # n/a Batch n/a Temperature 18 C Relative Humidity 45% Comments Room cleaned according to SOP CLN-002

Note: Temperature and humidity are only relevant if the room is supposed to be controlled.




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STEP 199. Select Operator Sign button, enter credentials and confirm.

STEP 200. Log out, log in as a QM

STEP 201. Select Review signature button, enter credentials.

STEP 202. Click

STEP 203. Navigate to: Logs Equipment Log

Equipment Log screen:




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Note: Start Date, End Date, Cleaning Agent, Product Name or Part # and batch refer to the previous batch run in the equipment unless the cleaning is a periodic cleaning or not associated with a batch. This is controlled by your facility’s SOPs. Note: Equipment numbering convention to consider: YYY-XXX where YYY is the alphabetic acronym for the equipment and XXX is the sequential number of that type of equipment for that specific item.

STEP 204. Select Hyperlink for Equipment number

STEP 205. Click

STEP 206. Enter data as shown below:

Equipment Number a Equipment x Activity Calibration Start Date/Time Use current date and time End Date/Time Add 4 hours to above Cleaning Agent, Lot # n/a Prod Name or Part # n/a Batch n/a Comments Equipment calibrated according to Equipment SOP




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STEP 207. Have an Operator and Project Manager/Quality Manager each sign for the activity.

STEP 208. Click




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Master Batch Records

STEP 209. Navigate to: Batch Record -Master Production Record

Through this option a user can add, edit, view, search, sort, hide, copy, version up, scale up and print Master Production Records or Master Device Records as well as create BPRs. New Print icons are available on the Summary screen:




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Colums on the leftmost side:

Columns on the rightmost side:

To use the Hide function, select the checkbox for those records you want hidden and confirm. To see those records, select “Hidden” from the search Status drop down as search. To unhide, select the checkboxes of hidden items you wish to “unhide” and confirm. To see only active records select “Active.” “All” displays all records.




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Application Rules:

• Project Title, Product name, Client, Author, Formulation ID, and Theoretical Batch Yield and associated Unit are mandatory

• The Product Name is tied to the project title and is a concatenation of Product name, strength, primary container and suffix.

• Bill of Materials, Equipment, In-Process tests, manufacturing instructions and signatories (at project personnel level) are all editable via the MPR tabs until a record is locked down

• is used to edit a record • is used to delete a record




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• Approvers are assigned responsibility of approving MPR records via checkboxes on the Project Personnel page and must sign for an MPR in order to create Batch Records from the MPR.

• Approvers can be edited via the Personnel tab in a Project • Upon confirmation of first assigned MPR approvers’ signature for MPR approval, the

record is locked down Note: if only one signatory is assigned, the first approval locks the record for good.

• Only one signature for reject will reject and lock the batch • A new version and/or a copy of the rejected batch may be created • An MPR, including attachments, will be read-only once all assigned MPR Approvers

approve the record. • Each MPR can have multiple versions.

• MPR versioning is controlled by signatures and a version button ; a version must have the same Project title, product name, formulation ID, Theoretical Batch size, strength (if applicable) primary container (if applicable) suffix(es) (if applicable) and BOM list amounts and units.

• A Copy of an MPR must begin with a change in one or more of the following fields: project title, product name, client, formulation ID, and Theoretical Batch yield.

• Once an MPR or version copy has been created, it cannot be deleted but may be hidden. • In order to use the scale up functionality , the MPR used as a template must have had

the “Auto populate BOM Qty on Mfg. instructions” checkbox checked. • The “Auto populate BOM Qty on Mfg. instructions” checkbox can only be used to auto

populate the BOM quantities on the manufacturing instruction “Actions” when each material in the BOM is used in the batch and the entire amount/unit Qty designated on the BOM is used in one step. The scale up feature will scale up/adjust the material amounts on the BOM The scale up feature will scale up/adjust the material amounts on the Manufacturing instructions but NOT the min and max values, as the system does not assume that doubling the amount would double the parameters.

• Theoretical Batch yield is a read-only display of the theoretical yield as shown on the cover page. This will be updated when the scale up calculator is used.

• Users have the capability to select materials to be used. • For each chosen material, a unit must be chosen. • Changes can be made until MPR is approved and locked or rejected. • The “Quantity Required” refers to the amount of each part# that will be staged for

production. This can include components, filters, bottles, capsules, caps, packaging labels, etc.

• “Composition” refers to the amount of material that will be within a set unit of the final product when manufacturing is completed. (e.g. mg/mL, mg/capsule, g/serving, etc.)




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• Copy materials from another MPR button allows user to select MPR from which to copy all materials amounts and units.

• “Delete all steps” button deletes all records on that screen including those not copied from another MPR.

• “MPR #” automatically assigned to Master record and displayed on the summary screens for MPRs and BPRs for uniqueness and traceability Note: according to the FDA, An MPR is a Master template for Batch Records; a batch record must be created for each and every time the recipe/instructions detailed in the MPR are followed for batch production.

Master Record Cover Page

STEP 210. Click

STEP 211. Select Project Title: “Training-Finished Encapsulated Product” from dropdown menu.

Note: Version will auto-populate upon confirmation of page.

STEP 212. Enter the following information:




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Project name* Training-Finished Encapsulated Product Product Name* Finished Encapsulated Product FG- Client* NEW Author* Project Manager Formulation ID* Dry Run Product Strength** 14 Theoretical batch yield*

1002

Batch Size 1000 BPR Unit * kg Primary Container** Amount/Primary Container

Primary Container

Amount Unit g # of Containers 10 Purpose Training Supplement, Digestive health Scope Dry Run Attachment select “Browse” button and select an excel, word, PDF or jpeg file

• * required • ** populated with product name if identified during product name definition

STEP 213. Click




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Master Record: Bill of Materials STEP 214. Navigate to: Materials (Bill of Materials Tab)

STEP 215. Click

STEP 216. Click to select a material

STEP 217. Select part # hyperlink for “Training-Raw Powder” for version 1 from list




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STEP 218. Enter data from table below into fields:




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STEP 219. Click

STEP 220. Repeat steps for Vegetarian Capsules, Primary Container

Material/Part#

Training Raw Material

Training Vegetarian Capsules

Primary Container

Quantity Required

3 1000 100

Unit kg ea ea Composition 3 1 3 Comp. Unit g ea ea

The Copy BOM button allows users to copy BOM materials amounts and units from selected MPR.

Filters facilitate navigation to desired MPR from which to copy data.




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Master Record Equipment STEP 221. Navigate to: Master Production Record Equipment

Application Rules: • Users have the capability to add, delete and copy equipment to be used. • Changes can be made until the MPR is approved or rejected.

STEP 222. Click




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STEP 223. Select x(a) from drop down box

STEP 224. Click

STEP 225. Optional: repeat for Scale or other equipment entered from drop down

Master Records In-Process Tests STEP 226. Navigate to Master Production Record In Process Tests

Note: these steps may alternatively or also be integrated into the manufacturing instruction steps.

STEP 227.

Application Rules:

• Users have the capability to add, copy and delete in-process tests that must be performed during batch production.

• Test and Method fields are required fields. • Changes can be made until MPR is approved.

STEP 228. Click




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STEP 229. Enter 1.00 for test number

STEP 230. Select “Micro” from the Tests drop down

STEP 231. Select “USP (62)” from the Method drop down

STEP 232. Enter “Check for defects” in the Test Purpose field

STEP 233. Enter “<5% failure per batch” in the Test Specification field

STEP 234. Click

Master Production Record Manufacturing Instructions STEP 235. Navigate to: Master Production Record Manufacturing Instructions




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Definitions for Manufacturing Instruction Screens: • Step Number: numerical identification manually assigned to a manufacturing instruction

so that the system can sequentially order the instruction steps. • Part # upload arrow: If a component or material is to be used for completion of a step, it

can be added by using the prompt arrow to display the Part # selection screen • Version #: the version number of the required Part # has to be selected to assure the

material with the proper specifications is used. • Inventory: If a material is to be used in this step, select the “Inventory” check box. This

will alert the operator during batch manufacturing to enter the amount of material that is used at that step and this will decrement the amount from inventory in real time.

• Performer: If a signature of the activity performer is required at this step, select the check box.

• Verifier: If a signature of a verifier is required at this step, select the check box • Material Action: shows action as “Measure (amount/unit/) of (material name)” (smart

field updated with scale up if auto pop check is selected) • (if autopop check in checked) Action: autopopulated statement to “measure out x (unit)

of (material)” • Action: the instructions for operators to follow in order to complete the step • Range: If an activity requires a measurement, then a range of acceptable values can be

entered. • Target: (smart field updated with scale up function if auto pop check is selected) an

activity requires a measurement, then a target value can be entered. • Min: (smart field that gives error on BPR) numerical entry for the minimum allowable

Qty for step with material. (associated with Unit) • Max: (smart field that gives error on BPR) numerical entry for the maximum allowable

Qty for step with material. (associated with Unit) • Unit: Unit of measure tied to the Target and Range, Min and Max. • Attachment: word, excel, PDF, jpeg file attachment e.g. SOPs, device spec drawings,

spreadsheet formulas, forms, links to videos, COAs for material lot used, workflow diagrams, pictures of machinery, etc.

Application Rules for MPR Manufacturing Instructions:

• MPR Version is a read-only field. • Steps will be sequentially ordered (ascending) • Part number upload arrow displays a material selection list based on the MPRs Bill of

Materials. • If Performer and Verifier checkboxes are checked in the MPR manufacturing step, then

those same boxes will automatically populate in the BPR, prompting mandatory digital signatures.

• If the inventory checkbox is checked in the MPR manufacturing step, then that same box will automatically populate in the BPR, allowing the user to deplete an amount in inventory Associated with that step.




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• If the Auto populate BOM QTY on Mfg. Instructions is checked on an MPR cover, o The BOM amounts and associated units will populate actions on the instruction

steps. o The approvals tab will display error messages when material part #s included on

the BOM are not included in a manufacturing instruction step. o The approvals tab will display error messages when material part #s included on

the manufacturing instruction step(s) are not included BOM. o The approval tab will display error messages for any materials in the BOM that

were identified in more than none manufacturing instruction step. o The MPR manufacturing instruction steps will display error messages if the target

defined in the BOM is not within range of the min and max entries.

• Data that is not confirmed will be lost. Always confirm data in fields before navigating via hyperlink or button to other functions.

STEP 236. Click




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STEP 237. Enter “PREP” in the Action field STEP 238. Select the “---” for the Unit dropdown, number step “10”

STEP 239. Click (Step will be labeled “10”)

STEP 240. Click STEP 241. Enter data as below:

Step 10 Unit “---” Action “Check room log for

cleaning of prep room according to SOP-CLN-xxx”




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STEP 242. Click

STEP 243. Click STEP 244. Enter 20 for the step number Note: it is best practice to leave numerical leeway between steps for possible additions during editing or in later versions of the MPR. Decimals can be used for this purpose but many employ a method of using number ranges for certain activities, e.g. 100s for pre and 200’s for mixing and weighing.

STEP 245. Select the upload arrow

STEP 246. Select “Training-Raw Powder” from the Selection list (version # auto-

populates) STEP 247. Select checkboxes for Inventory, Performer and Verifier Note: If the “Auto populate Qty on BOM to Mfg. instructions” checkbox was chosen on the cover page, an action will appear automatically instructing the operator to “Measure out Qty/unit of material part#”




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STEP 248. Enter data as shown:

Action Tare scale. Record Scale Equip # and Calibration date.

Min .99 Max 1.2 Target 1.0 Range .99-1.2 Unit kg

STEP 249. Click

For Training purposes two steps are sufficient; however, if more practice is needed, one can certainly use the examples below to create multiple steps and signature sets. Bear in mind that each of the signature boxes checked must be signed for at the batch record level. Manufacturing steps to consider for a GMP MPR include:

• Counting and verifying labels – expiration date, product name, country of origin, dosage or recommended scope, any mandated info (e.g. for dietary supplements signifying product is a Dietary Supplement; not intended to cure treat or prevent disease; not endorsed by FDA)

• Checking Cleaning room logs, • Checking equipment cleaning logs and calibration dates • Obtaining line clearance from QC (environmental testing) or operators (debris and last-

batch labels cleared away/cleaning) • Staging materials (checking statuses, writing lot numbers and expiration dates, moving to

weigh station, cleaning, prepping utensils and bags/bowls) • Calibrating, tare weights, calibration dates of Scales/ recording • Turning on filters, air controls, water skids, machinery • Individual steps for operators to follow in order to run any of the machinery

o Time to do so o Speed/level/

• Gowning/Donning PPE safety equipment – gloves, respirator, booties, hairnets etc.




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• Weighing – actual weights recorded, each ingredient needs 2 signatures (controlled step) • Mixing- methods and tools • Recording times of holding, mixing, heating, • Recording environmental factors; temp, humidity • Reconciliation of bottles, caps, labels, as well as FG/WIP samples/retains, rejects • In-Process Testing-

o visual uniformity checks; blended powder, dissolved solution o pH, viscosity, o Micro, Chem or other test samples set aside, etc. o QA inspection of capsules/bottles/seals/label placement, o Average weights of capsules/fill volumes, etc. o Packaging instructions, from label to pallet

Note: for each step; decide what the risk to consumer safety or business reputation is for that action not being completed correctly and mandate performer and verifier signatures accordingly. Controlled steps such as exact weights or times or those requiring calculations should always be checked for both signatures to be compliant with FDA regulations. Manufacturing Instruction Steps can be copied from other MPRs




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Dynamic Fields: Custom MPR/BPR fields and formulas See Advanced Topics: Dynamic Fields for detailed examples and rules

Create fields to fill in or display data from custom fields or from system data. Create formulas from custom and system fields. Call to formula results to use in other formulas or to display. Create drop down boxes and choices for operators at the BPR level.




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Master Record: MPR Approvals Navigate to: Master Production Record MPR Approvals




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MPR Approver names and associated roles with the options to sign for approve or reject are displayed. Note: Error messages specific to steps and or material part #s will appear for authors and approvers to see before attempting to sign. These errors pertaining to inventory use must be resolved before an MPR can be approved. STEP 250. Select the Sign button for approve STEP 251. Sign with credentials and confirm STEP 252. Make a change to one of the manufacturing instructions or add or delete an

instruction.

• Note: Signature for first approval and first signature for unlock are logged and the Approve and Reject buttons are available to all signatories. (log out and log in as another signatory) Sign with the unlock button to unlock the record; write in a reason for unlocking the record in order to proceed.

Application Rules for MPR Approvals:

• Users that have been identified as “MPR Approver” via checkbox on the Project Personnel screen will populate the MPR Approval screen. (Note: this defaults to none; all the PMs and QMs in the system for each new project are assigned)

• Once one approval signature is confirmed, the entire MPR record is locked but can be unlocked by a second required signatory and the record can be updated. A reason for unlocking the record is required. Note: if only one signatory is assigned to a project, an MPR for that project will be permanently locked upon first approval.

• Any new updates create a new version which will copy the current version except the for approval actions.

• MPR must be approved before it can be issued/viewed/executed as a BPR.




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• All information previously entered into the MPR (except Approvers) shall be visible and locked/un-editable to ensure each time a batch is made it is made using the exact same set of instructions.

• • Another required approver may unlock an MPR to make edits, at which point the first signatory must sign again for the new changes.

Create a BPR directly from the MPR Summary screen. For those roles with access to the MPR screen (PM, PS, QM) a shortcut to creating Batch records is now available. The same rules as outlined in the BPR creation rules apply to the underlying code but there are less steps and there is less room for operator error.

Note: Only those MPRs in an approved status have the BPR creation icon available.




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Batch Production Record

STEP 253. Navigate to Batch Record Batch Production Record

Application Rules for Batch Records: • Through this option a user can add, edit, view, search, issue, perform, approve and print

BPR Records. • Batch records can be printed before, during and/or after completion of the record directly

from the print icon on the summary screen




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• A Batch can only be created from an approved MPR (exception: Approval signatures populate based on the project personnel asignments) to ensure that each time a batch is produced it is made using the exact same set of instructions.

• The system will assign a unique batch number to each BPR record. • Users may add in a legacy number for their batch records in the production # field • Cover Page, Materials, Equipment, In Process Testing and Manufacturing Instruction

tabs shall show all the information that was locked down in the corresponding MPR. • Cover Page, Materials, Equipment, In Process Testing tabs shall be read-only • All tabs are locked until the Issuance signature is confirmed by QA • Issuance button prompts the application to check whether the materials in the

BOM/formula/recipe are*: o in an approved state o with signed off specifications o from a qualified vendor (currently assumed by ordering process) o available in sufficient amounts

• Once the Batch has been issued, the Manufacturing Instruction tab allows for the entry of step results in real time during manufacturing by operators

• Once any required data is confirmed the status of the batch goes from issued to in-process • Users that have been identified as “BPR Approver” on the Project Personnel page will

populate the Executed BPR Approvals screen. • The system will allow a user to create multiple Batch Production Record (BPR) copies

from an approved MPR. • The system will automatically assign batch numbers based on the formula: MPR #,

MPR version, sequential batch #. *Exceptions are for those opting to toggle off specifications and/or inventory checks. Batch Production Cover Page STEP 254. Navigate to: Batch Record BPR Cover Page

Show drop downs allow user to see only records of a certain status: Generated: A batch that has been created but not issued Issued: A batch that has been issued but does not have a manufacturing date In-Process: A batch wherein any data has been confirmed on any step Locked: A batch that has one approval signature confirmed. (no subsequent unlocking) Reviewed: A record with all required approval signatures Added to Inv: A batch that has been added to inventory via the BPR cover page.




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Users may show Hidden, Visible, or both hidden and visible records (all).

Leftmost columns:

Columns on the right hand side:

STEP 255. Click




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STEP 256. Select “Training-Finished Encapsulated Product” from the Project Title

drop down box STEP 257. Select “Training-Finished Encapsulated Product-FG-14-Primary Container”

from the Product name dropdown box The form is auto-filled with information from the MPR.

STEP 258. Enter “Training Exercise” in the Production # field

STEP 259. Click




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STEP 260. Click STEP 261. Toggle to or sign in with a QA role

STEP 262. Click ; enter credentials and confirm

STEP 263. Click Note: Production number is now locked down upon Batch Issuance via QM signature. This is to protect traceability.

Certain items of the batch record are now editable using on the BPR Cover page which sends user back to




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Note: Users may sort batch records by double clicking on the desired column name. STEP 264. Select the Materials tab to view the Bill of Materials (read-only) STEP 265. Select the Equipment tab (read-only) STEP 266. Select the In-Process Tests tab (read-only)

The Cover Page also allows for attaching documentation and printing the Batch Production Record. Note: the cover page attachment approved in the MPR can be overridden at the BPR level.




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Batch Record Manufacturing Instructions STEP 267. Navigate to: Batch Production Record Manufacturing Instructions Tab

STEP 268. Log out and log back in as an Operator

STEP 269. Click for Step 10




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STEP 270. Enter “Room was cleaned @ 0600 by JDoe with 70% alcohol lot 222” in Result field.

STEP 271. Click STEP 272. Navigate to: Batch Production Record Manufacturing Instructions Tab Application Rules for Batch Production Record Manufacturing Instructions:

• The system will allow the operator to enter data in select fields in the BPR manufacturing steps.

• The operator may enter results, comments and deviations on the manufacturing step as needed and update any attachments as necessary.

• The operator may access the inventory use records for approved material lots and use inventory in real time.

• The material lot numbers, amounts used and signatures for each use within a manufacturing instruction step will be auto-populated in the step and logged in the use history in inventory management.

• Confirming a deviation comment adds a new signature button for a mandatory QA approval of the deviation

• Signature buttons signify that signature is required • Records with missing signatures for performer verifier or QA approval shall not be

Approved nor sent for use in inventory. • For steps with materials and the inventory box checked at the MPR level for those MPRs

with the Auto populate box checked, the automated action step will display. • Error messages will be displayed when the inventory amount used is not within the min

and max parameters set at the MPR level and deviations will be automatically opened. • Material uses for the part number of the selected step will be displayed on the step after

confirmation of uses. Multiple uses will be added to total the amount used for the step and displayed as converted to the unit chosen at the Tmaterial screen.

• Yellow checks indicate that the step is in progress and some required items have been entered but required data is still pending.

• Inventory is required to be used if inventory button is present; amount is required to be within min max limits unless QA has signed for deviation approval

• A result is required to be entered in the result field even if that result is “Y” or “ok” or “done”

• Any required signatures must be confirmed • If all required activities are performed for a step, that steip will have a green check

indicating it’s completion. • All checks must be green in order for signatories to be able sign for the approval of batch

review.




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•

STEP 273. Click for step 20

STEP 274. Click




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Application Rules for Inventory Use:

• If the inventory checkbox was checked in the corresponding step in the MPR, then the box will be checked in the BPR, alerting the operator to deplete the specified amount in inventory. An Inventory button appears

• Selecting the Inventory button will bring up the inventory sub-screen with the material that is available for use. The inventory can be depleted at this step in real time. Depleting inventory will require operator signature.

STEP 275. Select the receipt number hyperlink for “Training-Raw Powder”

STEP 276. Click

STEP 277. Select current date from calendar popup STEP 278. Enter 3 in the Qty field




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STEP 279. Select Unit “g” from the drop down box STEP 280. Enter “Training” in the Purpose field

STEP 281. Click STEP 282. Enter credentials and confirm

Note: if an amount outside of the min and max defined parameters for the step is confirmed whether in one action or multiple actions, a deviation will be initiated.

STEP 283. Click

STEP 284. Click for “Performer Required”




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popup when scanner is used:





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STEP 286. Hand mouse control to another user to sign using their credentials, or toggle to Quality/PM/ role and enter credentials for verifier and confirm

STEP 287. Select the appropriate navigation option in the “Action after Confirm” dropdown

STEP 288. Click STEP 289. Sign for any additional steps entered as an option Application Rules for Manufacturing Instruction Summary screen

• Yellow checks indicate actions are required • Red checks indicate an error which stops the workflow • Green checks indicate all required actions for that step are completed • No check indicates that the step only requires that a result be entered • A result must be entered into each step, all required signatures must be confirmed and a

useage record for material within min max range is required (besides in the case of a signed deviation) if the inventory button appears on step in order for the step to be considered completed and marked green.

Note: Make sure to use material first and always confirm your results!

Batch Record Approval STEP 290. Navigate to: Batch Production Record Executed BPR Review STEP 291. Select sign button




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STEP 292. Click enter credentials and confirm STEP 293. Repeat for each mandated signature

Note: Signatures for MPR and BPR approvals are UserID-specific, not role specific, so you must be signed in as the user requested.

Application Rules

• The system will lock a BPR including all its data once all assigned BPR approvers have confirmed their approval signatures.

• The first signature confirmation locks a batch • All required signatures must be confirmed for the “Add Batch to Inventory” button to

appear on the cover page. • The system will allow a user to create a PDF report of the BPR record.

STEP 294. Navigate to the BPR Cover page tab

STEP 295. Click Application Rules for adding Inventory

• The system will allow a user to add the material from a BPR to the inventory as a WIP or a Finished Goods type material.

• The system will assign a Receipt Number to any WIP or Finished Goods material that is added to inventory via a batch record. (Requisition numbers for in-house produced goods FG/oWIP will be 0 as they were not requisitioned but manufactured with a batch record.)

STEP 296. Enter 3 into the Qty




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STEP 297. Verify that “kg” is the unit

STEP 298. Click


STEP 300. Click

Sale/Distribution of WIP/FG products STEP 301. Navigate to Inventory Material Use STEP 302. Select the update arrow for “Training - Finished Encapsulated Product” STEP 303. Enter 1000 for the Qty Use STEP 304. Enter “Sent to Distribution center” / “sold to…” STEP 305. Select sign button and enter credentials. STEP 306. Confirm There is also a hyperlink from the BPR summary page to any batch use/sale history (for those which have been added via the “add batch to inventory” button)




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Audit Log STEP 307. Navigate to Audit Audit Log STEP 308. Enter your UserID in the person field STEP 309. Select dates including today or dates of other known data entry STEP 310. Select types of access and a screen and click search. Data appears




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STEP 311. Select Hyperlink for a URL to see details STEP 312. Navigate to Audit Audit Attribute STEP 313. Select attribute from drop down and select search STEP 314. Select hyperlink for additional information (old value, new value, function)




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Reports

Current Inventory is a direct report that does not require entry of any additional data for the report to be run.




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Inventory value report

Low inventory Levels Report requires user to select a below “stock %” on which to report.

Inventory value Report




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Traceability Reports require data to be selected before applicable data can be displayed. Select a lot/production number to see what material lot #s were used in making the batch.

Select a raw or iWIP material and vendor lot # to display all of the batches wherein that vendor lot # was used

Barcode Labels and Scanning Barcode Scanning Functions: Personnel Badges/ Login and Material Labels. (included in your subscription and must be toggled on by your InstantGMP support specialist) Specs for barcode scanners: You may choose a standard USB or wireless scanner with a 3of9 font (very common,) which can be found online and in office supply stores for as little as $14 USD. The two I tested with most are TaoTronics TT-BS012 and YHD 1100. The YHD is plug and play and very inexpensive. Another is X000N0XR2L WoneNice USB Laser scanner black. We recommend DYMO Label writer 450 and the “Badge Label” setting, DYMO labels #30857 for ease of use and having done lots of printing ourselves, but there are newer comparable models available such as the 500.




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Rules for Scanned badges/error messages: If the badge of the user who is logged on is scanned, complete the digital signature. If the badge of a user who is not logged on is scanned, another field for the password appears and displays the message "You are not logged into this computer, Please enter your password". If the badge is not scanned, the user can enter their name and password to complete the digital signature If the badge is out of date, display "Batch is out of date and not valid" If the user is not authorized for the action, display "User is not authorized for this action" If a non-valid bar code is scanned, display "Please scan a valid user badge" If the wrong User ID/password combination is entered, display "User ID or password not recognized" Barcode scanner – Material Handling Users can print a label with the status of a material and a barcode for each material receipt – at the Status level. Go to the Inventory->Inventory Status. You can also ask your training specialist to toggle on the feature to automatically print labels upon receipt in order to print all quarantine incoming material labels.

Select for a material receipt to be printed. Ensure that you select the correct printer and size the label to the correct template. (this will vary depending on your version of adobe, printer, browser, OS, etc.) I have chosen badge label.




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Select and scan the label. The Inventory Status page for that Receipt/Vendor lot# will appear where the QM can change the status to “Approved.” A new label can be printed with the new status for that Lot/Receipt number.




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Using inventory with the scanner

Select on Inventory Management -Inventory Use screen or Manufacturing instruction –Inventory Use screen.

Scan the label. Note: You can also type manually into the field and then select Scan button. The Inventory Use screen for scanned receipt/vendor lot # will appear and operators may manually enter how much material they used. Operators may manually sign or sign with their badge.




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Operators may sign with badge by scanning their badge on any signature screen or popup and confirming. Remember to confirm record on main screen to save the signature to the record.

To set up and print a badge, go to Setup->Personnel and select no earlier than today’s date for a start date and an expiration ( consider synching this with yearly training updates or password change procedures e.g. every 3 months. Select the “Create Badge” button. Note: the option to create a badge only appears after the first time a personnel record is confirmed. If this is a new record, go back into the record via the update icon and the option to create a badge code will appear.




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Click Navigate back to the Personnel screen; select the print icon in the row fasociated with whom you’d like to print a badge.




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Return to any screen with a signature prompt and select the button. Scan the badge.

Click Bin Location Barcode Label Labels for bins and/or bin locations may be printed to adhere them to warehouse shelving or location bins. The print icon is located on the HWWbinlocation screen within setup:




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The bin location of a material may be changed by navigating to Inventory>Inventory Management.

From there, if using a scanner, select the “Scan to Change Location” button, scan the material label and then scan the destination bin label and confirm.




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Alternatively, users may select the hyperlinked receipt number for the material they wish to move and then select the change location button.

Error messages will display “Bin not found” or “The label is not a bin label or is not properly read” if improper format or not existant bin locations are entered.




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This allows users to manually select the new location of the material via facility, room and bin location drop downs:




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Advanced Topics: Hiding Materials Users may Hide materials so that those materials will neither show up on specification lists, requisition/P.O. lists, nor BOM selection Lists. Materials with a type of WIP oWIP or FG will not show up on MPR creation selection lists regardless of whether they were previously included in projects. In order to Hide a material, users must log in with the role of PM, PS, QM, INV or IO. Ensure that the filter for “Visible” is chosen for the filter:

Select the box in the “Hide” column to the left of each record to be hidden.




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Select Confirm.

Records disappear from HWW Material screen Select the Filter for “hidden” and select Search. Hidden records are shown.

To Unhide materials, select the check in the boxes for hidden materials you wish to un-hide.

select confirm.

Materials will be shown under “visible” filter.




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Additional training videos are available online at http://www.instantgmp.com/support Additional remote training is available via Trainer’s calendar online, http://www.instantgmp.com/support/appointment-request or a quote can be requested via [email protected] Special Functions Integrated Scales: For use with specific scale models that have protocols applied to your instance. Preparation for automated weight recording

Setup

1. Ensure the equipment is in the Equipment list in Setup.

http://www.instantgmp.com/support

http://www.instantgmp.com/support/appointment-request

mailto:[email protected]




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2. Ensure InstantGMP has completed the integration of the equipment (indicated by a DBADM electronic signature and date on TEquipment).

3. Navigate to the Equipment list in Setup.

4. Print the Label for the selected equipment.




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5. Affix the Label to the equipment.

Serial Interface App

Note: For balances or scales that are not designed to plug and play with Windows 10, a serial interface application must be installed on the computer that is connected to the

balance or scale. InstantGMPWebDeviceInstaller1.0.0.0.exe This program must be running in the background when the scale integration functions are used.

See separate document in advanced training for installation instructions.

Note: this functionality only works from within the batch record and not from the non-batching material use screen.

Scan and Get Weight during batch manufacturing

1. Navigate to the manufacturing instruction of a batch production record where a material needs to be weighed.

2. Tare equipment, then measure out the required amount of material.

3. Allow equipment to stabilize.

4. Click the “Scan and Get Weight" button on the manufacturing instruction screen.




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5. A popup will appear for the material scan.




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6. Scan the bar code label on the material – the popup will update the material name and receipt.




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7. Scan the bar code on the equipment

8. The application autofills the equipment name, equipment number,weight and unit data.

9. The popup allows for signature entry

10. Scan your personnel badge or enter your Username and Password.

Note: make sure your browser does not autofill in your name and password.

11. The Inventory Use screen will display the digital signature.




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12. Click “Confirm” to return to the manufacturing instruction screen – the Receipt #, Vendor Lot #, Quantity and Unit, digital signature, Equipment # and Equipment Name will automatically be displayed.




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13. The Weighing activity will automatically be entered into the Equipment Log with the corresponding Start and End Dates, Product Name, Batch # and digital signature of the user showing up as the Operator’s signature.

Version History

Version Date

(MM/DD/YYYY)

Description of Change

00 02072014 New Document 01/ 2.045 070214 Made changes for the new Unit table/page/workflow.

02/ 2.045.008 09/10/14 Updated the new specification workflow.

03/2.045.009 11/17/14 Updated with new batch material use workflow

04/2.050.001 05/18/2015

The default Role can be assigned from the personnel screen. Personnel may login immediately after role assignment on this screen. (p 21) Added Optional Features section (p20) Added note about ability to sort by batch issuance stamp (p89) Deleted signatures for Material vendor qualification and updated screen shot. (p 39) Updated new specification workflow (pp 40-45) Updated reports to reflect being sourced from within GeneXus. (pp 99-102)




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05 / 2.051.002 07/22/2015

Added a section for the new barcode scan features for user badges and material labels. Added Sign with badge add tests and browse buttons to icon glossary. Edited Order to sort with new icon in glossary.

06/ 2.052.001 12/2/2015

Deleted CPC, addressed client change, deleted : Selecting “Y” from the “Qualified Vendor” dropdown will return all materials that have qualified vendors. “N” will return all materials whose vendor has not been qualified. “Clear” will return all materials.”

2.053.002 12/13/2016 project changes, Product name, Primary container, copy function, version up function, scale up function,

2.054.002 05/09/2016 Min max patch – new error messages 3.000.001 05/09/2016 See release notes below

3.000.002, 3.000.004, 3.000.101, 3.000.102,

08/05/2016

Only active users counted in # of users, specifcation version shown on all read only spec data pages MPR ID # auto assigned New batch Number formula: MPR # + MPR Version + BPR # increment. Material label dimension changed to 2:1 Added * to mandatory fields Searches work for secondary words; Date format toggle Lots of new columns and data on main panels Print option for MPR and BPR on HWW screens Scale integration ADM no longer added to projects Attachment corruption issue fixed




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3.001.001 02/27/2017

R1364 – Add asterisks “*” for required fields on all screens R1509 - add search for Material Name and part # to requisition screen R1532 - Add Part # Column to Primary Container Selection List R1546 - Show: Default show sort drop downs R1564 - Toggle date format (supersedes R497) R1589 - MPR HWW - add new filters to summary screen R1599 - resize/restructure data on top pane so qty is visible R1610 - Add "used" to Qty column on iGMP.HTbInventoryUsage01 R1614 - Use By Filter on Current Inventory Report R1615 - Add columns to Inventory Value Report for Production # and Batch # R1620 - Move "Low Inventory Levels" report to just below "Inventory Value" on the main menu R1627 - Add Print column to HWWMPR and HWWBPR R1629 - Scale integration (Modern Health Concepts)

3.001.101 09/07/2016

Hide materials, Create BPRs directly from MPR R1611 - Hide Materials R1619 - Allow a BPR to be generated directly from an MPR D929 - receipt and status labels missing use by date D931 - scan and get wt popup confirm spelling

3.002.001 10/20/2016

Advanced Topics (separate document) partial receipt and split lots. Export to excel function on certain HWW screens. Material Receipt changed to Pending Receipt Material Status merged with Inventory Management Current inventory in quarantine report merged with current inv report Status Change signature now behaves as other signatures with a popup.

3.002.002 02/27/2017

R1608 - Data Import Spreadsheet for v3.0 (extension of 1293 for v2.051) D622 - Remove "Qualified Vendor?" from HTbMaterial01 D873 - security - general - make sure changes get into trunk for release

3.002.003 02/27/2017 1640, 1706




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3.002.004 02/27/2017

R1099 – Limit to # of Enabled Users R1604 - Add Version # column to HWWMaterialSpecification2

3.002.005 02/27/2017 1725

3.003.001 03/07/2017 1713, 1678, D1011, D944, D975, D973, D967, D965 (no updates needed for defects)

3.002.006 04/06/2017

R1739 – Add "Filter by Material Types" to Search Pane in Inventory Management Screen R1738 - Assign a new receipt # to each material that is added to inventory R1727 - Assign receipt number to completed batches added to inventory via the add batch to inventory button see 1738

3.002.007 04/06/2017 New product Wizard 3.002.007 04/13/2017 Reworded scale integration section.

3.002.008 3.003.001 06/13/2017

Deleted old release notes, added new, reset password function, new screenshots, BPR check color rules, edits for workflow changes

3.004.001 07/21/2017

Deleted old release notes, added set up menu item for inventory import, new filters on copy steps from another MPR screenshots R1721 – Inventory Import overview (details in separate advanced topics document) R1807 – iGMP.HCmMPRMIOavAttributes should be named Dynamic Fields or similar (currently called manufacturing instructions) (goes in advanced topics) R1806 – Add column for MPR number # to the "Select MPR from which to copy" screen (s) for BOM, equipment, in-process tests, manufacturing instruction tabs R1817 – Add filters to "Select MPR from which to copy" HWWPromptMPR2 (screenshot for 1806/1817) D1179 – MPR -project title mis-labelled mpr, client product code - BOM, equipment, in-process tests, screenshot




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Recent Release Notes:

InstantGMP Release Notes version 3.004.001 07/11/2017 Job Title Signature Date C.T.O. Angelo Nardone

07/13/2017

QA Gretchen Rizor

07/11/2017

New Functionalities

• Materials and inventory can now be imported from a spreadsheet that is downloadable from the application. This new functionality allows users to easily transition their inventory information from legacy systems to the InstantGMP Inventory Management solution. The solution includes import of:

o Materials o Specification version placeholders with automatic signatures that reference paper

specs OR for further definition and signature within IGMP o Inventory Status, Purchase Orders, Receipt IDs and Inventory On-Hand

Improvements

• In order to simplify the process of copying data from one MPR to another, when selecting “COPY MFG STEPS FROM ANOTHER MPR,” we’ve added filters to the selection table for all data available on the MPR Selection screen.

• We renamed the Dynamic Fields main definition screen for a more intuitive identification. • We’ve updated the rules that trigger the Production Date on a BPR as follows:

o When any data is entered on the following fields is confirmed: Result Comment Deviation

o When inventory is used on any step o When the Operator or Verifier sign a step

Fixes

• Specification sampling instructions are word-wrapped and no longer truncated on the PDF.




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InstantGMP Release notes for version 3.003.001 04/17/17 Job Title Signature Date C.T.O. Angelo Nardone

05/11/2017

QA Gretchen Rizor

05/10/2017

New Functionality

• Dynamic Fields o Allow user-defined fields to be created for Batch Production Record (BPR)

Manufacturing Instructions. Dynamic Fields can be used to: capture or display a date capture or display an established amount of text capture or display numeric values display and capture information from checkboxes or selection lists determine or calculate and display the results of high level calculations

within and between manufacturing steps display selected fields from the BPR Cover Page or use these field’s data

in calculations o Dynamic Field Control Types – determine what kind of data is processed

Edit box – a single customizable labelled entry field will be displayed on the BPR.

Check Box – a single customizable labelled clickable box that has a check mark if clicked, empty otherwise. Used to capture a value that has only two choices (e.g. Yes or No).

Dynamic Combo Box – a customizable data set displayed as a drop down box.a

o Dynamic Field Attribute Types If Attribute Type = Attribute, this is a selection list that includes all

the dynamic fields that have been created in any of the Manufacturing Instruction Steps.

If Attribute Type = System, this is a selection list that includes all the static fields that have are available from the MPR.

• System Attribute Types from Manufacturing Instruction o Target o Min o Max




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o Range o Fill Weight Required o Weight Record o Step (Step Sequence)

• System Attributes from Cover Page o Product Strength o Theoretical Batch Yield o Batch Size o Batch Unit o Primary Container o Amount/Primary Container o # of Containers

o Dynamic Field Formulas Algebraic expressions that can be used to calculate the value for a

dynamic field. Formulas can use normal algebraic expressions, e.g. +, -, /, *, () and can

be nested within additional parentheses. Formulas can use Conditional operators, e.g. >, <, >=, <=, <> Formulas can be comprised of any combination of dynamic fields from a

step and/or from other steps and/or with system attributes from the cover page and/or steps., e.g: a formula for Total Made could be:

[!Actual Batch Yield@Step=650!] + [!Samples@Step=660!] +[!Rejects@Step=670!] Where the Actual batch yield captured in Step 650, (which was calculated from dynamic step attributes and cover page system attributes) is added to the Sample amount captured in Step 660 and added to the Reject amount captured in Step 670.

The formula described will be executed and will populate the attribute field in a corresponding BPR manufacturing instruction in real time as an operator documents production of a batch.

o Dynamic Fields on MPRs and BPRs. All dynamic fields and formulas will be copied from an existing

Master Production Record to another Master Production Record when any of the following functions are executed:

• Copy MPR • Version Up MPR • Scale Up or Down MPR • Copy Manufacturing Instructions from another MPR




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Any time a Batch Production Record is generated from a Master Batch Record, all dynamic fields and functions will be transferred to the BPR.

All dynamic fields and functions will be displayed on the corresponding MPR and BPR printouts.

• Internet of Things (IoT) o Equipment Integration with encrypted duplex communication and control allows

asynchronous communication from any integrated device to and from InstantGMP. Note: This improvement allows for automatic data capture from equipment without physically prompting data transfer such as by pressing a print button on equipment.

o This feature will provide an internet enabled connection between InstantGMP and equipment or devices with a serial I/O.

Web Server running InstantGMP

1.0 g

Local ComputerRunning “WebDevice” App

1.0

Serial Device

1.0 g

InstantGMP accessed through company specific URL

1.0 g

InstantGMP accessed through company specific URL

o The serial device is connected through a USB cable or RS-232 cable to a local

computer that is running the “WebDevice” application which in turn is in communication with the InstantGMP software running on a virtual server in a web services host.

o Each serial device is tied to a customer specific IGMP instance and has a unique encryption key and explicit communication protocol.

o Any other local computer that is connected to the internet and has access to the customer’s InstantGMP specific instance can access data that is communicated to and from the WebDevice.

• Reset Password functionality. o Users are now automatically prompted to follow a universally recognized

path to reset password so there is neither need to call IGMP customer support nor find the end user company site ADM.




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Improvements

• E-Mail address is mandatory for all personnel. • Creation Date for MPRs and BPRs is now visible as a new column on their respective

summary screens. • Vendor Lot Traceability report was updated to:

o Include part numbers next to the material names o Only show Materials that have been used in BPRs.

• A more extensive set of rules was implemented to improve performance when a BPR needs to be reviewed. Now all the steps are checked to ensure all signatures and all results are properly completed before a BPR Review can be signed.

• Traceability was improved by adding Receipt numbers, Batch # and Production # on Inventory screens.

• Consistency was improved by using the same orders, when possible, on searches and by standardizing “delete” records icon where available.

Fixes

• Updated Excel export of the Vendor Lot Traceability report to include Material Name and Vendor Lot #.

• Corrected situation where ADM was shown as part of projects and part of the approver for BPRs.

• Added missing “use By Date” to Receipt and Status labels. • Corrected signature showing duplicated names. • Updated barcode signature on MPR Approval page. • Changed workflow - after using “Scan to Use” function the screen returns to the prior

one. • Updated Pending Receipt Screen to show Qty Rcv for partially received materials. • Fixed issue where under certain circumstances the files attached to BPR instructions

would not show on the summary screen. • Corrected font format and print size on MPR and BPR PDF printouts. • Fixed missing signature label on Inventory Use. • Improved material selection search function on Requisitions. • Updated “Add Batch to Inventory” function. • Updated Equipment Log Export to show Equipment Type. • Fixed Requisition search so proper material is selected each time. • Corrected minor spelling errors.




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END

APPROVAL BLOCK

APPROVALS TITLE SIGNATURE/DATE

Reviewed By:

Gretchen Rizor

Quality Assurance

07/24/2017

Approved By:

Richard Soltero, PhD

President

07/24/2017




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Documents

FirefoxIGMP runs best on - InstantGMP, Inc. · 2020-06-04 · InstantGMP MES/VAPE/PRO/INV/MD is a database application designed to manage GMP manufacturing of any FDA regulated product