SOP for Vendor Qualification and Approval

PURPOSE

To lay down the procedure for selecting and approving the vendors.

SCOPE

This procedure applies to vendor approval for all Raw Materials, Packaging materials, and Labeling materials.

RESPONSIBILITY

The Head of Purchase and Head of QA are responsible for approving vendors.

PROCEDURE

Vendors for Critical Raw materials

A.  The material used in New Products

• R & D shall generate tentative specifications for the material to be used in the product. Based upon these specifications, a Purchase requisition is sent to the Purchase Department for procurement of material generally from 2-3 vendors, along with the quantity required. The following points must be included in the Purchase requisition.

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1. Pharmacopoeial Status of material if any.
2. Any in-house specifications should be included based on the literature survey.
3. Quantity of sample required.

• Purchase Department on receipt of the Purchase requisition shall identify the vendor for required material and shall initiate Vendor assessment as per the following procedure

1. The purchase Manager shall send a vendor assessment cum registration form (Annexure I), to the proposed vendor.
2. The filled-up Questionnaire shall be sent by the vendor to the Purchase Manager.
3. The Questionnaire shall be sent to QA for technical evaluation.
4. QA shall evaluate the Questionnaire based on the Evaluation Matrix (Annexure-II).
5. If required Vendor audit shall be conducted to confirm/affirm of vendor's Quality system by the representatives from QA, If felt necessary.

• If the vendor qualifies and meets the requirement of cGMP based on a questionnaire, the Purchase Manager shall procure a sufficient sample of the Material along with a Certificate of Analysis, which shall be forwarded to Quality Control for technical evaluation.
• On receipt of the sample, QC shall analyze the sample as per the agreed specifications.
• If the sample meets the specification and the quality system of the vendor is found adequate, the name of the vendor shall be considered for inclusion in the approved vendor list.

B.  Vendors for Material used in Existing Products

• Need for the additional vendors arises for the following reasons :

1. Inadequate supplies
2. Commercial aspects
3. Deterioration in quality
4. Improper supply

• The purchase Manager shall send a vendor assessment cum registration form (Annexure I), to the proposed vendor.
• The filled-up Questionnaire shall be sent by the vendor to the Purchase Manager.
• The Questionnaire shall be sent to QA for technical evaluation.
• QA shall evaluate the Questionnaire based on the Evaluation Matrix (Annexure–II).
• If required Vendor audit shall be conducted to confirm/affirm of vendor's Quality system by the representatives from QA, If felt necessary.
• If the vendor qualifies and meets the requirement of cGMP based on the Questionnaire,
• The purchase Manager shall procure a sufficient sample of the Material and a Certificate of Analysis, which shall be forwarded to Quality Control for technical evaluation.
• On receipt of the sample, QC shall analyze the sample as per the agreed specifications.
• If the sample meets the specification and the quality system of the vendor is found

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Vendors for Non-critical Materials

Vendor's qualification for Non-critical materials shall be done as follows

• The purchase Manager shall conduct an initial assessment of the proposed vendor for Excipients by the following procedure. The purchase Manager shall send the initial assessment form (Annexure I, Annexure II, Annexure III) to the proposed vendor.
• The filled-up initial assessment form shall be sent by the vendor to the Purchase Manager
• The initial assessment form shall be sent to CQA and DRF for technical evaluation.
• If the vendor qualifies for initial assessment criteria, the Purchase Manager shall procure a sufficient sample of the material along with a Certificate of Analysis, which shall be forwarded for technical evaluation.
• On receipt of the sample, DRF shall analyze the sample as per laid down specifications.
• If the sample meets the specification and the vendor qualifies in an initial assessment, the name of the vendor can be considered for inclusion in the approved vendor list.

Vendors for Packaging Material

• The purchase Manager shall conduct an initial assessment of the proposed vendor for Packaging Material by the following procedure.
• The purchase Manager shall send the initial assessment form (Annexure-I, Annexure-II, Annexure-III) to the proposed vendor.
• The filled-up initial assessment form shall be sent by the vendor to the Purchase Manager.
• The initial assessment form shall be sent to CQA for technical evaluation.
• If the vendor qualifies the initial assessment criteria, the Purchase Manager shall procure a sufficient sample of the material along with a Certificate of Analysis, which shall be forwarded to the manufacturing location.
• The concerned manufacturing location shall analyze the material and if required machine suitability studies shall be carried out.
• In the case of packaging material other than Printed Packaging material, If the sample meets the specification and the machine suitability studies, the name of the vendor can be considered for inclusion in the approved vendor list.

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• In the case of printed packaging material, If the sample meets the specification and the vendor qualifies in the initial assessment, an audit shall be done of the printer`s facility jointly by the QA and Purchase Department representatives.
• Based on the report of the audit, vendors' names can be considered for inclusion in the Approved Vendor List.

Vendor's Quality Audit

• The Vendor Audit shall be conducted on the following aspects

1. Quality Management
2. Personnel
3. Documentation
4. Production
5. Quality Control
6. Complaints and Product Recall
7. Self Inspection

• On completion of the audit, an audit report shall be prepared.
• The audit report shall have the following details

1. Name and Address of the Vendor Audited
2. Date of Audit
3. Persons Present
4. Audit Conducted By
5. Summary – This shall include the various observations during the audit
6. Opinion – This shall include the opinion of the auditors on whether the vendor should be approved or otherwise.
7. Recommendations – This shall include recommendations of the auditors to improve the weak areas of the vendor identified during the audit.

• Based on the outcome of the audit a decision shall be taken regarding the incorporation of the name of the vendor in the approved vendor list. The intimation of the same shall be sent to the Purchase Department, Quality Assurance Department, Production Department, and Stores.
• The manufacturing location may be asked to provide feedback on commercial supplies. Based on their feedback, the name of the vendor may be retained/deleted from the approved vendor list.

Abbreviations

FPS: Finished Product Specifications

I.H.: In House

Lab.: Laboratory

MBF: Master Batch Formula

NPDP: New Product Development Policy

No. : Number

RMS: Raw Material Specifications

SOP: Standard Operating Procedure

Revision History

Nil

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