Documentation and Records - · PDF fileDocumentation and Records: ... documentation where the data has been superseded by a full set of new data. ... (plan, OJT) Revision

Documentation and Records: Harmonized GMP-PIC/S Requirements

PIC/S PE 009-12 (Introduction Part I, II, ANNEX)

Sirivan Pomchaksin

Expert 10

The Government Pharmaceutical Organization (GPO)

TOPICs

Why ?Document

Important

UPDATED ! PIC/S : 2015History

Of PICs GMP Guide

PE -009

Chapter 4,6

Annex 15

Doc Type

&

Model

CREATION CONCEPTs

GOOD DOCUMENTsDoc Control

Syst. & Life cycle

WHY are documents so important?

Communication

Cost

Audit trail

If it was not written it was not done.

9/19/2016 6

1 January 2013 PE 009-10 Revision of Chapter 4 (Part I)

Revision of Annex 6,7,11 and 13

1 March 2014 PE 009-11 Introduction of QRM principals in

PIC/S GMP Guide - Part II

Revision of Annex 2 and 14

1 Oct 2015 PE 009-12 Revision of Annex 15

9/19/2016 7

UPDATED PIC/S : 2015 (PE 009-12)

‘Documentation and Records’GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

• Introduction

• PART I : CHAPTER 4 DOCUMENTATION

: CHAPTER 6 (6.7-6.10 ) QC DOCUMENTATION

• PART II : SECTION 6 DOCUMENTATION AND RECORDS(API Mfg))

• Annex11 : Data ,Data Storage (ผนวก ๑๐)

• Annex15 : DOCUMENTATION including VMP (ผนวก ๑๔)

What has changed?

ประกาศกระทรวงสาธารณสขุ เรื่อง การก าหนดรายละเอียดเกี่ยวกับหลักเกณฑ์ และวิธีการที่ดีในการผลิตยา แผนปัจจุบัน และแก้ไขเพิ่มเตมิหลักเกณฑ์ และวิธีการที่ดีในการผลิตยา แผนโบราณตามกฎหมายว่าด้วยยา พ.ศ. ๒๕๕๙ (ราชกิจจานุเบกษา 14 กย 2559)

CHAPTER 4: DOCUMENTATION

- Stronger emphasis

on holistic

compliance

- Type of Documents

- Retention period

V.9

- Include all form of document media

- Fully defined docs within the QMS

- Diff. types of docs & their req.

- Retention periods

- Line clearance

- Real-time testing

- Activities of the authorized person

- More detailed list of processes req.

SOPs- Logbooks

V.11

V.12

V.10*Big

Change

Chapter4 DOCUMENTATION

• Principle

• Required GMP Documentation (by Type)

• Generation and Control Documentation

• Good Documentation Practices

• Retention of Documents

• Specifications

• Manufacturing Formula and Processing /Packaging Instruction• Batch Processing Record• Packaging Record

• Procedures and Records• Receipt • Sampling • Testing• Others

CHAPTER 4 DOCUMENTATION

PRINCIPLE

The main objective of the system of documentation

utilized must be to establish, control, monitor, and record

all activities which directly or indirectly impact on all aspects of the quality of medicinal products.

There are two types of documents used to manage and

record GMP compliance:

Instructions (direction, req.):free from error, available in writing

Records/Reports : be rendered in a human readable form.

To ensure the accuracy, integrity, availability and

legibility of document


REQUIRED GMP DOCUMENT (BY TYPE)

A document describing the GMP related activities of the manufacturer.

Site Master File

Instructions type

Specifications Protocols

Technical Agreement

Procedures

Manufacturing Formulae, Processing, Packaging and Testing Instructions

Record/Report type

Reports

For electronic records

regulated users should

define which data are to be used as raw data.

Records Alternatively the

certification may be

based, in-whole or in-

part, on the assessment

of the real timed data from batch related PAT.

Certificate of Analysis


GENERATION AND CONTROL OF DOCUMENTATION

4.1

Many documents (instructions and/or records) may exist in hybrid

forms, i.e. some elements as electronic and others as paper based.

Relationships and control measures for master documents, official

copies, data handling and records need to be stated for both

hybrid and homogenous systems.

Controls for electronic documentsTo ensure the integrity of the record throughout the retention period



4.2

Document should be designed, prepared, reviewed, and

distributed with care.

They should comply with the relevant parts of Product specification

files, Manufacturing and marketing authorization dossiers.

The reproduction of working documents from master documents

should not allow any error to be introduced through the

reproduction process.



4.3

Documents containing instructions should be approved, signed and date by

appropriate and authorized persons.(Qualified :EU )

Documents should have unambiguous contents and be uniquely identifiable. The

effective should be defined.

4.4

Document containing instructions should be laid out in an orderly fashion and be

easy to check

4.5

Documents within the QMS should be regularly review and kept up-to-date.

When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents.

4.6 Documents should not be hand written, ….sufficient space

should be provided for such entries.


GOOD DOCUMENTATION PRACTICE

4.7 Handwritten : clear, legible, indelible way

4.8 Records : at the time each action, traceable

4.9 Alteration : signed and dated

permit the reading of the original information

the reason for the alteration should be recorded


RETENTION OF DOCUMENT

4.10

Records is located, ensure the integrity, validated

4.11

Specific requirements apply to batch documentation which must be kept for one

year after expiry of the batch to which it relates or at least five years after certification of the batch by the Authorized Person, whichever is longer.

4.12

For other types of documentation, the retention period will depend on the

business activity which the documentation supports. Critical documentation,

including raw data (for example relating to validation or stability), which support

information in the Market Authorization should be retained whilst the

authorization remains in force. It may be considered acceptable to retire certain documentation where the data has been superseded by a full set of new data.


SPECIFICATIONS 4.13-16

Starting and Packaging Materials

Finished ProductsIntermediate and

Bulk Products

Starting and packaging material:

a)Name and internal code reference

Reference

approved suppliers ; original producer

specimen of printed material

b) Direction for sampling and testing

c) Requirement and acceptance limits

d) Storage conditions and precautions

e) The maximum period of storage before re examination


SPECIFICATIONS

Intermediate and Bulk Products:

Should be available for critical steps or if these are purchased or

dispatched. The specifications should be similar to specifications for

starting materials or for finished products, as appropriate.

Finished Products:

as starting

+ The Formula

+ Storage conditions and special handling precautions, where

application

+ The shelf life


MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 4.17-4.21

Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured.

Should include :

a) The name of the product, with a product reference code relating to its specification

b) A description of the pharmaceutical form, strength of the product and batch size

c) A list of all starting materials to be used, with the amount of each, described; mention

should be made of any substance that may disappear in the course of processing;

d) A statement of the expected final yield with the acceptable limits, and of relevant

intermediate yields, where applicable

Manufacturing Formula


Processing Instructions

work station are clear of previous products

equipment is clean and suitable for use.

Line Clearance

Reconciliation (Batch Packaging Record):

The quantities and reference number or identification of all printed

packaging materials and bulk products issued, used, destroyed or

returned to stock and the quantities of obtained product, in order to provide for an adequate reconciliation.

Packaging Instructions

Batch Processing Record

Batch Packaging Record


Name batch no. /dates /times Significant step, who check ,sign/date Actually weighed including batch no, IPC /Environment Major equipment Product yield /Reconciliation Deviation from Formula, processing operation

Approval for processing operation (validated)

++ Formula + Instruction

Batch Processing Record

Chapter 4 : Procedure and Records

Receipt (4.22-4.24)

• each delivery of starting material, Intermediate, primary, secondary

and printed PM

• Record + COA , supplier, manufacturer

Sampling (4.25) + Chapter 6 QC documentation (6.11)

+ Annex 8 sampling of starting and packaging material

• SOP : Methods, equipment, quantity

• Precaution avoid contamination, any deterioration

Testing (4.26) + Chapter 6 QC testing

• SOP at different stage ;approved method, equipment

• Record (6.17)

Procedure and Records

SAMPLING chapter66.11. The sample taking should be done in accordance with approved

written procedures that describe:

the method of sampling;

the equipment to be used;

the amount of the sample to be taken;

instructions for any required sub-division of the sample;

the type and condition of the sample container to be used;

the identification of containers sampled;

any special precautions to be observed, especially with regard to the

sampling of sterile or noxious materials;

the storage conditions;

instructions for the cleaning and storage of sampling equipment

Procedure and Records

TESTING chapte6

6.17. The tests performed should be recorded and the records should include

at least the following data:

a) name of the material or product and, where applicable, dosage form;

b) batch number and, where appropriate, the manufacturer and/or supplier;

c) references to the relevant specifications and testing procedures;

d) test results, including observations and calculations, and reference to any

certificates of analysis;

e) dates of testing;

f) initials of the persons who performed the testing;

g) initials of the persons who verified the testing and the calculations, where

appropriate;

h) a clear statement of release or rejection (or other status decision) and the

dated signature of the designated responsible person.

Procedure and Records (cont.)

4.27 Batch release ; authorized person(s) ,COA

4.28 Records; to facilitate recall

4.29 There should be written policies, procedures, protocols, reports, and the

associated records of actions taken or conclusions reached, where appropriate, for the following examples;

Validation and Qualification of

processes, equipment and systems Equipment assembly and calibration

Technology Transfer Maintenance, cleaning and sanitation

Personnel matter including signature

lists, training in GMP and technical

matters, clothing and hygiene and

verification of the effectiveness training Environment monitoring

Pest control

Complaints

Returns

Recalls

Change Control

Investigation into deviations and non-

conformances

Internal quality / GMP compliance

audits

Summaries of records where

appropriate (e.g. product quality

review)

Supplier audit

Procedure and Records (cont.)

Others SOP (4.27-4.32)

4.30 Major/critical manufacturing and testing equipment

4.31 Log books; chronological order , dates, identity of people who carried

4.32 An inventory of documents within the QMS should be maintained

Part I CHAPTER 6 : QUALITY CONTROL

6.7 LABORATORY DOCUMENTATION; Should be readily available to the Quality Control Department

Specifications Sampling procedures +Annex8

Testing Procedures and Records Analytical Reports and/or certificates Data from environmental monitoring, where required Validation records of test methods, where applicable Procedures for and records of the calibration of

instruments and maintenance of equipment.

Part I CHAPTER 6 : QUALITY CONTROL (cont.)

6.8

Any Quality Control documentation relating to a batch record

should be retained for one year after the expiry date of the batch.

6.9

For some kinds of data (e.g. analytical test results, yields,

environmental controls,…) it is recommended that records in a

manner permitting trend evaluation be kept.

6.10

In addition to the information which is part of the batch record, other

original data such as laboratory notebooks and/or records should

be retained and readily available.

Part II Chapter 6 DOCUMENTATION AND RECORDS (API)

6.1 Documentation and Specification

6.2 Equipment Cleaning and Use Record

6.3 Records of RM, Intermediate, API Labelling and PM

6.4 Master Production Instructions and Control Records

6.5 BPR

6.6 Laboratory Control Records

6.7 BPR Review

LIFE CYCLE OF DOCUMENT

TRAINING (plan, OJT)

Revision

Internal document:Numbering System

Each document is to be given a unique number consisting of 3 sections

Type of document

Department code / Owner

Sequential number

Each Form is to be given a unique number consisting of 2 sections

Document Number Sequential number

of the form

The DCC personnel issues hard copies of approved documents

on an as-requested basis.

COPY No.

Controlled copy will be stamped a unique,

controlled copy number with blue ink on

every page.

Uncontrolled copy will be stamped a unique,

controlled copy number with red ink

on every page. UNCONTROLLED

sign & symbol

The Obsolete or Superseded copies will be shredded to ensure they

are not used to perform work. Only the master document will be kept

as reference in Document Control Center after each of the pages has

been stamped in red with

S U P E R S E D E D

The cancellation of controlled copies and documents will be

shredded to ensure they are not used to perform work. Only the

master document will be kept as reference in Document Control

Center after each of the pages has been stamped in red with

C A N C E L L E D

sign & symbol

• All new or revised documents must pass through the document approval process by using the Document Action Request

• Document Preparer or Designee requests a controlled number from Document Control Center (DCC) for a new document.

• The DCC Personnel notify the Document Preparer at least 30-day before the periodic review date is due by using the Periodic Review Notice form

DOCUMENT CREATION/REVISION

DOCUMENT REQUEST & DISTRIBUTION

• The hard copies both Controlled and Uncontrolled can be requested by using Document Request Form.

• The DCC personnel will generate and send a Controlled Document Receipt Acknowledgement Form, included with the controlled hard copies to all users in the distribution list or the requestors while the users shall acknowledge the receipt of the document and must be returned the

superseded version to the DCC personnel.

THE USE OF ANNEX/FORM

• The use of annex (form for recording), the DCC personnel shall distribute the controlled copy to each unit operation as defined in distribution list.

• The form can be copied without the cover page for routine operation and each operation shall control them to stay in the current status.

DOCUMENT CANCELLATION

• The Document Preparer or Designee must be completed a DAR Form when he/she wants to cancel a controlled document. Approval signatures must include the following at minimum: • Document Preparer • Responsible Manager

• The DCC Personnel shall dispose of cancellation of controlled copies and documents by shredding to ensure they are not used to perform work.

• Only the master document will be kept as reference in Document Control Center after each of the pages has been stamped in red with “CANCELLED”.

DOCUMENT RETENTION

PINK DOCUMENT

• In training and trial period, the DCC will generate the documents for training purposes ::: Signed & Copied on Pink paper.

• Purposes of pink paper are also warning the operator who read them, these instructions have some changes. They will stay in pink paper for a month.

• When the Pink document is ready for removal from the training /warning status, the DCC should generate the master of White document with original approval same revision but set the new effective date .

• DCC distribute the white hard copy version to each operation units and get the pink document return to DCC.

DOCUMENT FORMAT : Header

THE GOVERNMENT PHARMACEUTICAL ORGANIZATION

RANGSIT PHARMACEUTICAL PRODUCTION PLANT

Document No.

SOP-QA-001

Rev. 02

Eff. Date:

4 Jul 2014TITLE DOCUMENT CONTROL SYSTEM

DEPARTMENT QUALITY ASSURANCE PAGE 12 of 24


RANGSIT PHARMACEUTICAL PRODUCTION PLANT

Document No.

SOP-QA-001_Annex01

Rev.02

Eff. Date :

4 Jul 2014TITLE DOCUMENT ACTION REQUEST (DAR) FORM

DEPARTMENT QUALITY ASSURANCE PAGE 4 of 5


RANGSIT PHARMACEUTICAL PRODUCTION PLANTDocument No.

SOP-EN-001

Rev.01

Eff. Date :

20 Oct 2013TITLE PREVENTIVE MAINTENANCE PLAN

DEPARTMENT ENGINEERING DIVISION PAGE 1 of 10

DOCUMENT FORMAT : Distribution List

Copy No. Area / Position

Master Document Control Center - QA

1 QA Manager

2 Manager of Rangsit Pharmaceutical Production Plant 1

3 Director of Validation Division

4 Director of Compliance and Quality System Division

5 Director of Quality Control Division

6 Director of Administration Division

7 Director of Production Division

8 Director of Warehouse Division

9 Director of Engineering Division

DOCUMENT FORMAT : REVISION HISTORYRev. No.

Change & Reason For changesEffective

Date

01 Initial Release 19 Sep 2011

02

02

03

Revised:

- Header: Change the plant name from

“Rangsit Manufacturing Plant” to “Rangsit

Pharmaceutical Production Plant”.

- Rearrange the sequence of topics.

- Distribution List: Rename and add the newly

divisions and sections as per the approved

organization chart. (p. 2/23)

- Internal Document Control System: remove

the section of Numbering System. (p. 10/23)

- Internal Document Control System: change

the process and lifecycle of pink document.

(p. 10/23)

- Attachment: remove template of VMP, QM,

BPR, SOP

Release in white paper

Revised:

- Updated the format of document header for

using in eQMS.

- Add definition of term that used in eQMS.

- Add detail for document control procedure in

eQMS

- Cancel the use of pink document

- Cancel the use of SOP-QA-001_Annex04

4 Jul 2014

4 Aug 2014

As per an

effective

date in

electronic

system

DOCUMENT FORMAT : Table of Contents

IMPLEMENTATION:DOCUMENT MODEL

Procedures

Operation Instructions

Records and Reports

Policy

Level 1

Level 2

Level 3

Level 4

Policy, Quality ManualDefine what will be done.

Procedures (SOPs)

Who, What, When

Work InstructionsHow

Evidences, Tag, Labels , Logbook

Level 1 for Whole GPO(GMP Cert., Quality Policy, Product Licence,

Quality Manual, Site Master Files)

Level 2 for Cross Functional Managing ProcedurePlant layout, QP, Qplan, Specification [BDR, BMR,

BPR, (Master)], SP, WQM, GMP Activity Plan

(Validation Master Plan, PM Plan, Review

Documentation Plan, etc.)

Level 4 for Quality Record & Report, Form (FM), Worksheet, Calibration Record, Tag, Logbook,

Water System Operation Record, บัญชีแม่บท

Level 3 for Operational ways of working at the functional levelValidation Protocol & Report (VP), Stability Study Protocol,

Work Instruction (WI), [BDR, BMR, BPR, (Original copy)]

Documentation

System

Quality

System

Materials

Packaging&

Labeling

Laboratory

Facilities,

Utilities &

Equipment,

IT/Comp.

Personnel

Production

การแบ่งระบบเอกสาร 6 หมวดตามลักษณะงาน

Document Control Instruction

• Document Numbering System

• Operation for Procedure and Instruction

• Specification and

• Operation of Record

• Document Distribution

• Generation of Validation Documents

• Generation of BDR/BMR/BPR

The first documents auditor asks ??

• SMF PE 008

• QM

• VMP Annex 15

• SOP list

• SOP PLANT GOWNING

SMF and Quality Manual

• Site Master Files

• What does the document contain?

• A SMF contains information about the GMP activities occurring specifically at a site – quality management, production and/or QC operations, or any closely integrated operations at nearby buildings. It doesn’t contain information about GMP operations completed elsewhere.

SMF PE008-4

EXPLANATORY NOTES FOR PHARMACEUTICAL MANYFACTURERS ON THE PREPARATION OF A SITE MASTERFILE

1. GENERAL INFORMATION ON THE MANUFACTURER

2. QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER

3. PERSONNEL

4. PREMISES AND EQUIPMENT

5. DOCUMENTATION

6. PRODUCTION

7. QUALITY CONTROL (QC)

8. DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS

9. SELF INSPECTIONS

SMF PE008-4

EXPLANATORY NOTES FOR PHARMACEUTICAL MANYFACTURERS ON THE PREPARATION OF A SITE MASTERFILE

Contents 5. Documentation

• Description of documentation system (i.e. electronic ,manual)

• When documents and records are stored or archived off-site (including pharmacovigilance data when applicable)

• List of types of documents/records

• Name and address of storage site and estimate of time required retrieving documents from the off-site archive

SMF PE008

• Appendix 1 Copy of valid manufacturing authorisation

• Appendix 2 List of dosage forms manufactured including the INN-names or common name (as available) of active pharmaceutical ingredients (API) used

• Appendix 3 Copy of valid GMP Certificate

• Appendix 4 List of contract manufacturers and laboratories including the addresses and contact information, and flow-charts of the supplychains for these outsourced activities

• Appendix 5 Organisation charts

• Appendix 6 Lay outs of production areas including material and personnel flows, general flow charts of manufacturing processes of each product type (dosage form)

• Appendix 7 Schematic drawings of water systems

• Appendix 8 List of major production and laboratory equipment

QM

• Quality Manuals

• What does the document contain?

• The Quality Manual is the overarching document of the QMS used to describe:• the quality policy of the business entity

• the boundaries, operations and process improvement of the QMS throughout the product lifecycle

• management responsibilities

• the road map of the key processes of the QMS and their relationship to each other.

• The Quality Manual may encompass multiple sites or a business entity operating within a larger site. Larger companies may not have a single document, or even call it a Quality Manual, but implement the quality policy using a series of individual documents – this is perfectly acceptable. Smaller companies may use the Quality Manual alone to describe their QMS (particularly in ISO 9001, though not so much in pharmaceutical companies).

What do the different regulations require?ollowinable comparesThe following table compares different regulations that have criteria for the SMF and/or a Quality Manual within the QMSegulations that have criteria for the SMF and/or a Quality Manual within the QMS.Regulation or Standard Site Master File Quality Manual

PIC/S GMP version 8 (in

use in Australia)

PIC/S GMP version 9

No (but preferred) No specific requirement

EU GMP

PIC/S GMP version 10Yes (mandated in Ch 4.) No specific requirement

EU and PIC/S SMF

guidance document

(essentially identical)

Yes (PIC/S used by TGA) No specific requirement

WHO SMF guidance Yes Yes

SMF Checklist

ANNEX15 VALIDATION

The key elements of the site qualification and validation program should be clearly defined and documented in a

validation master plan (VMP) or equivalent document.

ANNEX15 VALIDATION

I. Qualification and Validation policy;

II. The organizational structure including

roles and responsibilities for

qualification and validation activities

III. Summary of the facilities, equipment,

systems, processes on site and the

qualification and validation status

IV. Change control and deviation management for qualification and validation

V. Guidance on developing acceptance criteria

VI. References to existing documents

VII. The qualification and validation strategy, including requalification, where applicable

The VMP or equivalent document should define the

qualification/validation system and include or reference

information on at least the following:

ANNEX15 VALIDATION

DOCUMENTATION, INCLUDING VMP (2.1-2.10)

2.1 To support Km throughout the product lifecycle

2.2 All documents ;approved and authorized by appropriate personnel as defined in the pharmaceutical quality system.

2.3 Inter-relationship between document ; clearly defined

2.4Validation protocols should be prepared which defines the

critical systems, attributes and parameters and the associated

acceptance criteria.

2.5 Qualification documents may be combined

ANNEX15 VALIDATION

2.6

Where validation protocols and other documentation are

supplied by a third party providing validation services,

appropriate personnel at the manufacturing site should

confirm suitability and compliance with internal procedures

before approval.

Vendor protocols may be supplemented by additional

documentation/test protocols before use.

ANNEX15 VALIDATION

2.7

Any significant changes to the approved protocol during

execution, e.g. acceptance criteria, operating parameters

etc., should be documented as a deviation and be

scientifically justified.

2.8

Results which fail to meet the pre-defined acceptance criteria

should be recorded as a deviation, and be fully investigated

according to local procedures. Any implications for the

validation should be discussed in the report.

2.9

The review and conclusions ; against criteria/justification

change/recommendation

ANNEX15 VALIDATION

2.10A formal release for the next stage in the qualification and validation process should be authorized by the relevant responsible personnel either as part of the validation

report approval or as a separate summary document.

Conditional approval to proceed to the next qualification stage can be given where certain acceptance criteria or deviations have not been fully addressed and there is a

documented assessment that there is no significant impact on the next activity

LIST OF PROCEDURES

QMS Laboratory • Document Control System• การทบทวนของฝ่ายบรหิาร• การบรหิารความเสีย่งดา้นคณุภาพ Quality Risk Management• PERMIT TO OPERATE• ระบบการแกไ้ข / ป้องกัน (CAPA SYSTEM)• การควบคมุการเปลีย่นแปลง (Change Control System)• Product Quality Review• การตรวจสอบตนเอง (GMP Self-Inspection/Internal audit)• การสบืหาสาเหตขุองผลติภัณฑท์ีไ่มเ่ป็นไปตามขอ้ก าหนด

(Failure Investigation) • การอนุมัตปิลอ่ยผา่นยาส าเร็จรปู (Batch Release)• Incident Report• Investigating Out of Specification /Out of Trend Test

Results and control of Non-Conformance• Supplier Approval and Evaluation System• การรับคนืยา (Returned and Salvaged Drug Products)• การเรยีกเก็บยาคนื (Recall Procedure)• วธิกีารจัดการกับค ารอ้งเรยีนจากลกูคา้ Customer Complaint

Record (CCR)• การก าหนดรหัสสนิคา้ (Item Number)• การจา้งผลติยา เครือ่งส าอาง และการจา้งตรวจวเิคราะห์• การรับรองและทดลองผลติยาใหม ่

• การตรวจคณุภาพวตัถดุบิ• การจัดการวตัถดุบิและผลติภัณฑร์ายการใหมใ่นชว่งทดลอง• การตรวจคณุภาพบรรจภัุณฑแ์ละสิง่พมิพ์• Packaging and Printing Material Supplier • Approval and Evaluation• การตรวจและทดสอบยาส าเร็จรปู • การจัดท าขอ้ก าหนดมาตรฐานของยา (Product Specification) • การแสดงสถานะ การตรวจและทดสอบ • Analytical Results and Trends• การทดสอบความคงสภาพของยา• Microbiological Laboratory Management and Safety

Procedure• Storage and Handling of Reference Working Standards• Microbiological Laboratory Instrument Management• Microorganism and Media Management• Microbiological Testing Procedure• การส ารองขอ้มลูส าหรับคอมพวิเตอร ์(Backup of Electronic Data)

LIST OF PROCEDURES

Production Material

ตรวจสอบเฝ้าระวงัการปนเป้ือนของยากลุม่ Penicillinขัน้ตอนการผลติและควบคมุคณุภาพระบบการผลติการวางแผนการผลติและการควบคมุการผลติการจัดท าเอกสารประกอบการผลติและการก าหนด Lot No.การตรวจการปนเป้ือนของเชือ้จลุนิทรยีใ์นอากาศการวางแผนการผลติและการควบคมุการผลติการชีบ้ง่และสอบกลบัไดข้องผลติภัณฑ ์การเคลือ่นยา้ย จัดบรรจ ุจัดเก็บของหน่วยงานการผลติ การควบคมุสภาวะแวดลอ้ม การผลติ และการจัดเก็บ

การควบคมุกระบวนการผลติสิง่พมิพ์การจัดซือ้วตัถดุบิและบรรจภัุณฑ์การรับคนื / แลกเปลีย่นยาและเวชภัณฑ์การท าลายทรัพยส์นิทีเ่ป็นยาและเวชภัณฑ ์การจัดสง่สนิคา้แกล่กูคา้การรับ การเคลือ่นยา้ย การเก็บรักษา การจา่ยสนิคา้ส าเร็จรปูการสง่มอบสนิคา้ควบคมุอณุหภมูดิว้ยระบบ VMIการวางแผนความตอ้งการใชพั้สดขุองคลังวตัถดุบิ/บรรจภุัณฑ์การเคลือ่นยา้ย การจัดเก็บและการเบกิจา่ยของคลังวตัถดุบิ /บรรจภุัณฑ ์

LIST OF PROCEDURES

Facility Utility and Equipment Personnel

• การซอ่มบ ารงุ• การบ ารงุรักษาเชงิป้องกัน• การควบคมุการส ารองอะไหลแ่ละวสัดชุา่ง • การ Shut Down ระบบโรงงาน• การสอบเทยีบเครือ่งตรวจ เครือ่งวดั และเครือ่งทดสอบ • การสรา้ง การตดิตัง้ การควบคมุ และการรับรองงานทาง

วศิวกรรม• การออกแบบและการออกขอ้ก าหนดทางวศิวกรรม• การผลติและควบคมุคณุภาพระบบการผลติน ้าบรสิทุธิ ์

(Purified Water) ทีใ่ชใ้นการผลติยา• การก าหนดรหัสเอกสารแบบกอ่สรา้งงานสถาปัตยกรรม และ

วศิวกรรมระบบ

• Process Validation Procedure• Method Validation Procedure• Cleaning Validation Procedure• Validation and Monitoring of Microbiological

Laboratory Cleanroom and Aseptic Process• Excel Spreadsheet Validation

• การบรหิารทรัพยากรบคุคล• การฝึกอบรมพนักงาน• การควบคมุการเขา้พืน้ที่

Computer System นโยบายการตรวจสอบความถกูตอ้งของระบบคอมพวิเตอร์การขึน้ทะเบยีนระบบเพือ่ตรวจสอบความถกูตอ้งการบรหิารการเปลีย่นแปลงระบบเทคโนโลยสีารสนเทศการเก็บขอ้มลู GMP และทีเ่ก็บขอ้มลูการบรหิารการส ารองและกูค้นืขอ้มลูการบรหิารการเขา้ถงึของผูใ้ชง้านการบรหิารจัดการสนิทรัพยเ์ทคโนโลยสีารสนเทศ

CREATION CONCEPTs

REGULATION

Product Dossier (REG.)

Legislation GMP PIC/S

RESOURCE Personnel (Role & Responsibility)

Premise Equipment

RECORDS & REPORTS Traceability

REGULA-TION

RECORDS

& REPORTS

RESPONSIBILITY

RISKRESOURCE

5R RESPONSIBILITY Clear authorization

RISK Validation/Deviation /CAPA/change

GOOD DOCUMENTS

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