API Vendor Approval




         
Company Name
Q.A. Department
API Vendor Approval
Form No.
Revision No.:
Issue Date: 
           




Supplier No: ___________________  Date: __________________

Supplier Name: ________________________________________________________

Address & Ph. No: _____________________________________________________


Evaluation & Approval Summary: (Ref. SOP. No. SOP-08-011)

S. No.
Evaluation Parameter(s)
Compliance
     Status
Remarks
Sign (QA)
Yes
No
1
Certificate of Analysis Provided




2
Stability Data Provided




3
MSDS Provided




4
GMP Certificate Provided




5
Samples of 3 Lots Provided




5.1


5.2


5.3
Sample 1 Lot detail ( Lot No. ___________
Mfg. Dt. _________  Exp. Dt. ___________)
QC Test Results (Ref. No.) . ____________




Sample 2 Lot detail ( Lot No. ___________
Mfg. Dt. _________  Exp. Dt. ___________)
QC Test Results (Ref. No.) . ____________




Sample 3 Lot detail ( Lot No. ___________
Mfg. Dt. _________  Exp. Dt. ___________)
QC Test Results (Ref. No.) . ____________




6
Reference Standard Provided




7
Working Standard Provided




8
Cross reference detail of Working Standard with Primary Standard Provided




9
Validated Analytical Method Provided (In case of Non-Compendial API)




10
Whether Vendor is ICH Countries Approved




11
DMF Provided




12
Customer List for Cross Reference Provided





Remarks: Supplier Not Approved / Conditionally Approved / Approved for the supply of API_________________________


_____________                                                                                           ______________
Q.A. Manager                                                                                                  Director



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