Company
Name
|
QA Department
|
|
API Supplier Audit Check List
|
Form
No.
|
|
Issue Date:-
Revision
No:-
|
||
Supplier Name:
___________________________________________________________________________
Address:
___________________________________________________________________________
__________________________________________________________________________________
No
|
General Information
|
Remarks
|
1
|
Size of Organization (Small / Medium /Large)
|
|
2
|
Cleanliness & housekeeping
|
|
3
|
Total Personnel Strength
|
|
4
|
No of person in Manufacturing process
|
|
5
|
No. of persons on Quality Testing / Inspection
|
|
6
|
Laboratory Facilities with respect to GLP
|
|
7
|
Reliability Testing
|
|
8
|
In-process Testing Facility
|
|
9
|
Final Inspection & Testing
|
|
10
|
General Quality Management Practices
— ISO-9000
Quality System
— Written
Procedures on Quality
— Quality
Audits
— Quality
Record Keeping
— GMP
Audit
|
|
11
|
Evaluation of Material by Vendor Qualification
|
|
12
|
Material Delivery Status
|
Name
of Auditors:- ____________________________________________________________
Auditor 1:-
Auditor 2:-Auditor 3:-
Comments:-
____________________________________________________________________________
____________________________________________________________________________
________ ______________
Q.A. Manager Director