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1.0

VENDOR QUALIFICATION PROCEDURE

1.1

Vendor shall be qualified as per the steps described in the flow chart Appendix – I.

1.2

Vendor assessment Questionnaire as given in Annexure – I shall be sent to vendor with a requisition of samples to meet the specification along with Certificate of Analysis (COA) and Standard Testing Procedure (STP).

1.3

Quality Control (QC) shall test the sample as per the specification, based on request form from QA as given in Annexure-II.

1.4

Quality Assurance (QA) shall review

a) Executed vendor assessment Questionnaire.

b) Quality Control (QC) report of analysis.

1.5

Vendor audit shall be done for key Raw Materials and Primary Packaging material.

1.6

QA will initiate vendor audit along with Purchase, QC (if required) based on satisfactory questionnaire & analysis review.

1.7

Vendor Approval:

1.7.1

Vendor for key raw material of API/ Drug Product shall be approved based on

a)

Audit compliance

 

b)

Initial Trial batches, at least 1 or maximum 3 batches & generate minimum 3 months accelerated stability study data.

c)

Simultaneously observe the performance of material during production for its suitability.

1.7.2

For

Secondary

packaging

/

other

raw

material,

vendor

shall

be

approved

on

the

basis

of

vendor

assessment

questionnaire

and

Analytical data.

1.8

Approval of Existing Vendor

1.8.1 Existing vendors which were not qualified, shall be qualified through vendor assessment Questionnaire. If Questionnaire response is not satisfactory, then vendor audit shall be carried out for necessary quality compliance and vendor will be approved. Also generate trend analysis of 5 to 10 supplies on key quality parameters to support vendor qualification.

1.9 Documentation:

1.9.1 QA shall maintain all the records related to vendor qualification. Documents shall contain the following for each vendor as follows

1.9.1.1 Executed vendor Assessment Questionnaire

1.9.1.2 Related documents sent by Vendor with Questionnaire.

1.9.1.3 Analytical report of QC testing on Vendor sample

1.9.1.4 Audit Report (if any)

1.9.1.5 Copy of Change control documents

1.9.1.6 Stability study report if any

1.9.1.7 Annual quality data of respective material

1.9.2 QA shall prepare the approved vendor list and update the list once a year.

1.9.3 QA shall circulate the copy of the updated Approved vendor or vendor list to Purchase, QC and warehouse departments.

END OF DOCUMENT