STANDARD OPERATING PROCEDURE

Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:1 of 9

Effective Da
Revision No.: 00
Valid Upto:

Previous Revision Date Reason for Revision

--- --- New SOP

Subject Procedure for Vendor Qualification and Approval

1.0 PURPOSE
To lay down the procedure selecting and approving the vendors.

2.0 SCOPE
This procedure is applicable to vendor approval for all Raw Material, Packaging Material
and Labeling Material.

3.0 ABBRIVIATION/DEFINITIONS
Nil

4.0 RESPONSIBILITY
Head of Purchase & Head of QA are responsible for approving vendors.

5.0 PROCEDURE

5.1 Vendors for Critical Raw materials

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

 Pharmacopoeial Status of material if any.

 Any in-House specifications which should be included on the basis of literature survey.

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:2 of 9

Effective Da
Revision No.: 00
Valid Upto:

Previous Revision Date Reason for Revision

--- --- New SOP

Subject Procedure for Vendor Qualification and Approval

 Quantity of sample required.

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

5.1.1.2.1 Purchase Manager shall send vendor assessment cum registration form (Annex ure I), to
the proposed vendor.

5.1.1.2.2 The filled up Questionnaire shall be sent by the vendor to Purchase Manager.

5.1.1.2.3 The Questionnaire shall be sent to QA for technical evaluation.

5.1.1.2.4 QA shall evaluate the Questionnaire based on the Evaluation Matrix (Annexure –II).

5.1.1.2.5 If required Vendor audit shall be conducted to confirm/ affirmation of vendors Quality
system by the representatives from QA, If felt necessary.

5.1.1.3 If the vendor qualifies and meets the requirement of cGMP based onQuestionnaire,
Purchase Manager shall procure sufficient sample of the Material along with Certificate of
Analysis, which shall be forwarded to Quality Control for technical evaluation.

5.1.1.4 On receipt of sample, QC shall analyse the sample as per agreed specifications .

5.1.1.5 If the sample meets the specification and the quality system of the vendor is found adequate
, name of the vendor shall be considered for inclusion in approved vendor list.

5.1.2 Vendors for Material used in Existing Products

5.1.2.1 Need for the additional vendors arises due to following reasons :

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:3 of 9

Effective Da
Revision No.: 00
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Previous Revision Date Reason for Revision

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Subject Procedure for Vendor Qualification and Approval

 Inadequate supplies

 Commercial aspects

 Deterioration in quality

 Improper supply

5.1.2.2 Purchase Manager shall send vendor assessment cum registration form (Annex ure I), to
the proposed vendor.

5.1.2.3 The filled up Questionnaire shall be sent by the vendor to Purchase Manager.

5.1.2.4 The Questionnaire shall be sent to QA for technical evaluation.

5.1.2.5 QA shall evaluate the Questionnaire based on the Evaluation Matrix (Annexure –II).

5.1.2.6 If required Vendor audit shall be conducted to confirm/ affirmation of vendors Quality
system by the representatives from QA, If felt necessary.

5.1.2.7 If the vendor qualifies and meets the requirement of cGMP based on Questionnaire,
Purchase Manager shall procure sufficient sample of the Material along with Certificate of
Analysis, which shall be forwarded to Quality Control for technical evaluation.

5.1.2.8 On receipt of sample, QC shall analyse the sample as per agreed specifications .

5.1.2.9 If the sample meets the specification and the quality system of the vendor is found

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:4 of 9

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Revision No.: 00
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Previous Revision Date Reason for Revision

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Subject Procedure for Vendor Qualification and Approval

5.2 Vendors for Non critical Materials

Vendors qualification for Non critical materials shall be done as follows

5.3.1 Purchase Manager shall conduct initial assessment of the proposed vendor for
Excipients by the following procedure. Purchase Manager shall send initial
assessment form (Annexure I, Annexure II , Annexure III) to the proposed vendor.

5.3.2 The filled up initial assessment form shall be sent by the vendor to Purchase Manager

5.3.3 The initial assessment form shall be sent to CQA and DRF for technical evaluation.

5.3.4 If the vendor qualifies initial assessment criteria, Purchase Manager shall procure
sufficient sample of the material along with Certificate of Analysis, which shall be
forwarded to D.R.F for technical evaluation.

5.3.5 On receipt of sample, DRF shall analyse the sample as per laid down specifications.

5.3.6 If the sample meets the specification and the vendor qualifies in initial assessment
name of the vendor can be considered for inclusion in approved vendor list.

5.4 Vendors for Packaging Material

5.4.1 Purchase Manager shall conduct initial assessment of the proposed vendor for
Packaging Material by the following procedure.

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:5 of 9

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Revision No.: 00
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Previous Revision Date Reason for Revision

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Subject Procedure for Vendor Qualification and Approval

5.4.2 Purchase Manager shall send initial assessment form (Annexure I, Annexure II ,
Annexure III) to the proposed vendor.

5.4.3 The filled up initial assessment form shall be sent by the vendor to Purchase
Manager.

5.4.4 The initial assessment form shall be sent to CQA for technical evaluation.

5.4.5 If the vendor qualifies initial assessment criteria, Purchase Manager shall procure
sufficient sample of the material along with Certificate of Analysis, which shall be
forwarded to manufacturing location.

5.4.6 The concerned manufacturing location shall analyse the material and if required
machine suitability studies shall be carried out.

5.4.7 In 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 approved vendor list.

5.4.8 In case of printed packaging material, If the sample meets the specification and the
vendor qualifies in initial assessment, an audit shall be done of the printer`s facility
jointly by the representatives from QA and Purchase Department.

5.4.9 Based on the report of audit, vendors name can be consider for inclusion in
Approved Vendor List.

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:6 of 9

Effective Da
Revision No.: 00
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Previous Revision Date Reason for Revision

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Subject Procedure for Vendor Qualification and Approval

5.5 Vendor`s Quality Audit

5.5.1 The Vendor Audit shall be conducted on the following aspects

 Quality Management

 Personnel

 Documentation

 Production

 Quality Control

 Complaints and Product Recall

 Self Inspection

5.5.2 On completion of the audit an audit report shall be prepared.

5.5.3 The audit report shall have the following details

 Name and Address of the Vendor Audited

 Date of Audit

 Persons Present

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:7 of 9

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Revision No.: 00
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Subject Procedure for Vendor Qualification and Approval

 Audit Conducted By

 Summary – This shall include the various observations during the audit

 Opinion – This shall include the opinion of the auditors whether the

vendor should be approved or otherwise.

 Recommendations – This shall include recommendations of the

auditors in order to improve the weak areas of the vendor identified

during the audit.

5.5.4 Based on the outcome of the audit a decision shall be taken regarding incorporation of the
name of 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.

5.5.5 The manufacturing location may be asked to provide the feedback on commercial
supplies. Based upon their feedback, the name of the vendor may be retained/deleted in
the approved vendor list.

3.0 Abbreviations

DRF Dabur Research Foundation

FPS Finished Product Specifications

I.H. In House

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 STANDARD OPERATING PROCEDURE
Department: Corporate Quality Assurance SOP No.:

Area: Company wide Page No.:8 of 9

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Revision No.: 00
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Subject Procedure for Vendor Qualification and Approval

Lab. Laboratory

MBF Master Batch Formula

NPDP New Product Development Policy

No. Number

RMS Raw Material Specifications

SOP Standard Operating Procedure

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