API Supplier Audit Check List



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
  1. Management
  2.  No of Technical Persons
  3. Workers

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

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