Vendor Audit Question Air Re

Standard Operating Procedure

Title: Vendor Selection and Evaluation ______________________________________________________________________________________

This is not an approved copy unless stamped in red

File Location: Date Printed: Page 1 of 19

Document Owner

Procurement / Quality Assurance Manager

Affected Parties

All colleagues working in a team for vendor selection and evaluation process from the Procurement, QA, Technical Services and Laboratory Departments.

Purpose

To define the process by which Vendors are assessed and evaluated in accordance with the GMP requirements and Corporate Policies to create conditions for adequate material availability and adherence to specification.

Scope

Note: It is recommended to use this procedure in conjunction with SOP QMS-115.

This SOP describes the process for the selection of vendors for raw materials (Active Ingredients & Excipients), Packaging Components, Laboratory Supplies, Engineering Supplies, Bulk Product & Imported Finished Goods.

This SOP does not describe the process of selection of a Contract Manufacture, (see SOP QMS-110)

The process of vendor assessment and evaluation is divided into four phases.

Vendor Assessment

Phase 1. Technical discussions

Phase 2. General Vendor Audit

Phase 3. Item specific evaluation

Vendor Evaluation

Phase 4. Ongoing vendor evaluation

This phased approach is to be applied to the following purchasing activities. Specific details pertaining to each group are outlined in the procedure.

The progress of each Vendor, through this phased process, may be changed by management by means of documented discussion to be held on Vendor’s file.

A Vendor may be designated as approved without undergoing the following procedure under the following conditions:

• Via the legislation of local regulatory authority.

• Following submission of data as part of a product registration process.

It is the responsibility of Quality Assurance to ensure that all relevant requirements are communicated and adhered to.

Department Quality Management Document no QMS-045

Prepared by: Date: Supersedes:

Checked by: Date: Date Issued:

Approved by: Date: Review Date:





QMS-080 Audits

EHS Statement

EHS issues are to be part of the program when a Vendor is approved and reviewed. Their corporate responsibility should be noted. All EHS information with respect to a purchased product is to be sourced.

Table of Contents 1. Procedure..............................................................................................................................3 2. Specific Requirements for each Phase - Actives....................................................................5 3. Specific Requirements for Each Phase - Excipients ..............................................................5 4. Specific Requirements for Each Phase - Critical Packaging Components .............................5 5. Specific Requirements for Each Phase - Non Critical Packaging Components......................5 6. Specific Requirements for Each Phase - Laboratory Supplies ...............................................6 7. Specific Requirements for Each Phase - Engineering Supplies .............................................6 8. Specific Requirements for Each Phase - Bulk Product & Imported Finished Goods...............6 9. Appendix 1 – Flowchart- Vendor Selection and Evaluation....................................................7 10. Summery of Changes............................................................................................................8

1. Procedure

Responsibility PROCEDURE

See Flow diagram (Appendix - 1)

All employees Any unit within the organization may propose the need to source a new vendor of goods or services.

Procurement The initiator of the request must contact Procurement who will then commence the vendor assessment. It is the responsibility of Procurement to ensure the progression of the vendor through the vendor assessment process

Phase 1

Procurement

Source suitable vendor who is capable of manufacturing the material according to in-house Requirements, as per SOP QMS-115.

Vendors are selected using the following parameters:

• Ability to consistently supply material to the specification (laboratory records)

• Ability to deliver the required material in the quantities ordered (purchasing records)

• Previous experience with the supplier (raw material records, laboratory records, reject material/component forms)

• Cost of material

Ability to supply technical support where required.





2. Specific Requirements for each Phase - Actives

Active materials can only be obtained from approved manufacturers and in accordance with the registered details with the local regulatory authorities.

Phase 1, 2 & 3 are to be carried out in accordance with SOP QMS-115.

Phase 4

The evaluation is performed annually using information provided from laboratory trend cards reporting test results, stability analyses from post production stability monitoring, production records, special project minutes of meetings, and reject material/component forms.

If an adverse trend is detected by routine testing of the materials then the Laboratory Manager, in conjunction with the Procurement staff, will review, discuss and take appropriate action.

3. Specific Requirements for Each Phase - Excipients

There is no requirement to specify the manufacturer of an excipient material for the registration of a product. It is mandatory that the material supplied must comply with the grade and material specification registered as part of the registration process. The specification to which the material must comply may have been registered under the following conditions:

The manufacturer may be local or overseas based.

Phase 1, See SOP QMS-115.

Phase 2, 3 & 4, as per the procedure identified in this SOP.

4. Specific Requirements for Each Phase - Critical Packaging Components

In most instances the manufacturers of critical packaging components are identified as part of the registration process, yet this is dependent upon the class of material. This may be via the local regulatory guidelines or submission of actual data for the more recent registrations.


Phase 1, 2, 3 & 4, See SOP QMS-115.

5. Specific Requirements for Each Phase - Non Critical Packaging Components


Phase 1, 2

As per the procedure identified in this SOP.

Phase 3

Material Performance is conducted according to the material specification and performance in production. Results to be recorded on Form-390 and filed in Vendor File kept in procurement.

Phase 4

The evaluation is performed by QA and Procurement Departments annually using information provided from compilation of number of deliveries, degree of rejects, number and extent of problems encountered in production, stability data showing untoward trends attributed to material deficiencies or changes.





9. Appendix 1 – Flowchart- Vendor Selection and Evaluation

Chart Continued -

Need to

source new vendor is

identified

Procurement liaise for vendor

Identify possible

vendors

Send Supplier

Questionnaire

Purchase,

Sample & Testing

Discussion to proceed

Phase 2 required

Yes

General Vendor

Audit

Yes

Accepted

No

No

QA, Technical,

No

Form-385

Issue date

Vendor Audit Questionnaire (Ref. SOP QMS-045; QMS-080)

All information contained within this document will be treated as confidential between the Supplier and Buyer.


Vendor Company Name:

Supplier Site Address:

Supplier Business Address (if different):

Phone No: Phone No:

Fax No: Fax No:

E Mail: E Mail:

Material supplied to Sydco, covered by this questionnaire:

Is the Company a division/subsidiary of another corporation? Yes No N/A

If Yes, Please Specify

This questionnaire was completed by:

Name:

Job Title:

Date:

Signature:

Form-385

Issue date




Can you please provide full Supply chain(s) for the referenced material(s)

(i.e. Manufacturer, Testers, Providers of C of A / C of C,

Packers / Repackers and Storage & Distribution)

Yes N/A

If “Yes”, please list & explain:

Quality Management System

What is the basis of your quality system, i.e. ISO?

Please state your Certificate/Registration reference and appropriate dates:

Have any regulatory agencies inspected your facility in the last five years? Yes No N/A

If ‘Yes’, by whom, when and what were the results?

Are all procedures documented and approved? Yes No N/A

Are there change control procedures in place? Yes No N/A

Is there a procedure to notify customers of change? Yes No N/A

Are QA/QC responsibilities well defined and independent? Yes No N/A

Does QA/QC approve all analytical specifications and methods? Yes No N/A

How is a batch (standard quantity) defined?

What is the batch numbering system? (Please explain in detail)

Form-385

Issue date




Warehouse

Are storage facilities/equipment/ rented or personnel contracted? Yes No N/A

If “Yes”, please provide details.

Are receipt and release procedures documented? Yes No N/A

Is the supply chain documented? Yes No N/A

How is material status controlled? (i.e. Physical, system or labelling)

How is rejected material controlled? (i.e. Physical, system or labelling)

Is there an identified sampling area? Yes No N/A

Are all containers identified? Yes No N/A

Is a First-In-First-Out or First-Expiry-First-Out system in use? (Identify) Yes No N/A

Are shelf life/expiration dates used? Yes No N/A

Is Temperature (T°°°°), controlled and documented? Yes No N/A

Comments:

Is Relative humidity (RH%), controlled and documented? Yes No N/A

Comments:

Production

Is there more than one site or plant used for the manufacture

of the specified material(s)? Yes No N/A

If “Yes”, please provide details.

Is plant equipment labelled as to its status and contents? Yes No N/A

Is Pipe work labelled? Yes No N/A

Are critical processes validated? Yes No N/A

Does process documentation include:

Process instructions Yes No N/A

Cleaning instructions Yes No N/A

Cleaning records Yes N/A

Area clearance Yes No N/A

Are cleaning processes validated? Yes No N/A

Form-385

Issue date




Are there label disposal procedures? Yes No N/A

How are containers security sealed?

Is material clearly labelled, including waste and reject material?

No N/A

Computerized Systems

Do you have a list of the Computerized systems used by this facility? Yes No N/A

If “Yes”, do you identify the Computerized systems that are considered to have an impact on Quality of Product, or Service offered?

Yes No N/A

If “Yes”, how is this documented?

Does your Quality system cover the quality of Computerized systems? Yes No N/A

Do you have procedures in place for disaster recovery and restoring of data archives?

Yes No N/A

Do you have access security levels for the Computerized systems? Yes N/A

Do your procedures for validation cover the Computerized systems? Yes No N/A

Do you have anti-virus protection? Yes No N/A

Does the Change Control procedure include Computerized systems? Yes No N/A

Laboratories, QA & QC

Is an equipment use log in place? Yes No N/A

Are all instruments qualified (IQ, OQ, PQ)? Yes No N/A

Are all instruments calibrated? Yes No N/A

Is there a preventative maintenance program? Yes No N/A

Are there documented procedures for:

Sampling Yes No N/A

Sample handling Yes No N/A

Sample labelling Yes No N/A

Re-testing / Re-sampling Yes No N/A

Specification generation Yes No N/A

Analytical method generation Yes No N/A

Control and review of analytical methods Yes N/A

Form-385

Issue date




If Agent/Distributor involved, is the pipe work used on delivery to the agent/distributor dedicated?

Yes No N/A

Are the Agent/Distributor storage facilities dedicated?

No N/A

If “No”, what other substances are stored in the facilities?

Does the Agent/Distributor use dedicated filling lines?

No N/A

What instructions are given to the haulier for delivery to a Sydco site e.g. dedicated hoses, dedicated tanks, dedicated pumps, temperature control, and paperwork to accompany delivery?

Facilities & Housekeeping

Are there procedures for health and hygiene? Yes No N/A

Are rest/change/wash facilities separated from production areas? Yes No N/A

Are access restrictions implemented as needed? Yes No N/A

Do any production areas have special containment needs? Yes No N/A

Are waste disposal systems in place? Yes No N/A

Are there procedures documenting a pest control program? Yes No N/A

Are material Safety Data Sheets maintained? Yes N/A

Training

Is there a written training program? Yes No N/A

Are job-training needs evaluated?

No N/A

Is completed training evaluated and approved? Yes N/A

Are there completed written training records for all employees? Yes No N/A

Questionnaire reviewed for Buyer lead audit site by:

Form-390

Issue date

New Supplier Assessment (Ref. SOP QMS-045)


Supplier Name:

Results of the testing of first three deliveries:

Instructions on how to use this form:

1. Include all the material code numbers delivered on the one delivery and results of the testing in the corresponding row. If for example, more than one material code was delivered in the first delivery, list them all under Delivery 1 and so on for the subsequent deliveries. If more space is needed use a new form.

2. The materials are to be fully tested according to the respective Laboratory Control Test Methods.

3. Return the completed form to Procurement when completed.

Material code number

Batch number

Material conforms to current

specification?

Supplier C of A if available is in agreement with test results

Tested by:

(Signature)

Date:

Delivery 1

Date:

Delivery 2

Date:

Delivery 3

Date:

Comments:

Laboratory Manager: Date:

Documents

Vendor Audit Question Air Re