Standard Operating Procedure

Title: Vendor Selection and Evaluation

______________________________________________________________________________________

Department Quality Management Document no QMS-045

Prepared by: Date: Supersedes:

Checked by: Date: Date Issued:

Approved by: Date: Review Date:

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.

This is not an approved copy unless stamped in red

File Location: Date Printed: Page 1 of 19
Standard Operating Procedure
Title: Vendor Selection and Evaluation
______________________________________________________________________________________
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.

This is not an approved copy unless stamped in red

File Location: Date Printed: Page 3 of 19
Standard Operating Procedure
Title: Vendor Selection and Evaluation
______________________________________________________________________________________

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.
The manufacturer may be local or overseas based.

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

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

The manufacturer may be local or overseas based.

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.

This is not an approved copy unless stamped in red

File Location: Date Printed: Page 5 of 19
Standard Operating Procedure
Title: Vendor Selection and Evaluation
______________________________________________________________________________________

9. Appendix 1 – Flowchart- Vendor Selection and Evaluation

Need to
source new
vendor is
identified

QA, Technical,
Procurement liaise
for vendor

Identify possible
vendors

Send Supplier
Questionnaire

Purchase,
Sample & Testing

No Discussion
to proceed

Yes

Phase 2
required

Yes No

General Vendor
Audit

No Accepted

Chart Continued -

This is not an approved copy unless stamped in red

File Location: Date Printed: Page 7 of 19
 Form-385
Issue date
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)

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:

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

File Location: Date Printed: Page 9 of 19

 Form-385
Issue date
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)

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, Yes N/A

Packers / Repackers and Storage & Distribution)

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)

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

File Location: Date Printed: Page 11 of 19

 Form-385
Issue date
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)

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

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

File Location: Date Printed: Page 13 of 19

 Form-385
Issue date
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)

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
Yes No N/A
have an impact on Quality of Product, or Service offered?
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
Yes No N/A
of data archives?
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:
Yes No N/A
Sampling
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

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

File Location: Date Printed: Page 15 of 19

 Form-385
Issue date
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)

If Agent/Distributor involved, is the pipe work used on delivery to the Yes No N/A
agent/distributor dedicated?
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:

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

File Location: Date Printed: Page 17 of 19

 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.

Tested by:
Material Supplier C of A (Signature)
Material code Batch conforms to if available is in
number number current agreement with
specification? test results
Date:
Delivery 1
Date:

Delivery 2
Date:

Delivery 3
Date:

Comments:

Laboratory Manager: Date:

File Location: Date Printed: Page 19 of 19