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
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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