STANDARD OPERATING PROCEDURE

Department: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject 1.0 PURPOSE
To lay down the procedure selecting and approving the vendors.

Corporate Quality Assurance Company wide

SOP No.: Page No.:1 of 9 00

Date ---

Reason for Revision New SOP

Procedure for Vendor Qualification and Approval

2.0

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

3.0

ABBRIVIATION/DEFINITIONS Nil RESPONSIBILITY

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

4.0

5.0
5.1 5.1.1 5.1.1.1

PROCEDURE
Vendors for Critical Raw materials Material used in New Products 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: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject Date --Reason for Revision New SOP 00 Corporate Quality Assurance Company wide SOP No.: Page No.:2 of 9

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/ 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 5.1.1.5 On receipt of sample, QC shall analyse the sample as per agreed specifications . 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 affirmation of vendors Quality

5.1.2.1

Need for the additional vendors arises due to following reasons :

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STANDARD OPERATING PROCEDURE

Department: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject

Corporate Quality Assurance Company wide

SOP No.: Page No.:3 of 9 00

Date ---

Reason for Revision New SOP

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 5.1.2.4 5.1.2.5 5.1.2.6

The filled up Questionnaire shall be sent by the vendor to 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/ system by the representatives from QA, If felt necessary. affirmation of vendors Quality

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 5.1.2.9

On receipt of sample, QC shall analyse the sample as per agreed specifications . If the sample meets the specification and the quality system of the vendor is found

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STANDARD OPERATING PROCEDURE

Department: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject
5.2

Corporate Quality Assurance Company wide

SOP No.: Page No.:4 of 9 00

Date ---

Reason for Revision New SOP

Procedure for Vendor Qualification and Approval

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 5.3.3 5.3.4

The filled up initial assessment form shall be sent by the vendor to Purchase Manager The initial assessment form shall be sent to CQA and DRF for technical evaluation. 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 5.3.6

On receipt of sample, DRF shall analyse the sample as per laid down specifications. 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 5.4.1

Vendors for Packaging Material

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: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject
5.4.2

Corporate Quality Assurance Company wide

SOP No.: Page No.:5 of 9 00

Date ---

Reason for Revision New SOP

Procedure for Vendor Qualification and Approval

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 5.4.5

The initial assessment form shall be sent to CQA for technical evaluation. 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: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject
5.5 5.5.1 Vendor`s Quality Audit

Corporate Quality Assurance Company wide

SOP No.: Page No.:6 of 9 00

Date ---

Reason for Revision New SOP

Procedure for Vendor Qualification and Approval

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 Checked By Approved By

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STANDARD OPERATING PROCEDURE

Department: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject

Corporate Quality Assurance Company wide

SOP No.: Page No.:7 of 9 00

Date ---

Reason for Revision New SOP

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 FPS I.H. Prepared By Dabur Research Foundation Finished Product Specifications In House Checked By Approved By

STANDARD OPERATING PROCEDURE

Department: Area: Effective Da Revision No.: Valid Upto: Previous Revision --Subject
Lab. MBF NPDP No. RMS SOP

Corporate Quality Assurance Company wide

SOP No.: Page No.:8 of 9 00

Date ---

Reason for Revision New SOP

Procedure for Vendor Qualification and Approval

Laboratory Master Batch Formula New Product Development Policy Number Raw Material Specifications Standard Operating Procedure

END OF DOCUMENT

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