Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
ANNEXURE D (FOR STERILE)
STERILE BULK MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE
How is a lot/batch defined?
What is the lot number system?
Is there a way to denote the site of manufacture in the lot numbering system if multiple sites are
employed?
Approximate number of employees at facility
Approximate square footage of facility (including warehouse)
Management Profile:
Facility plant manager:
Quality control manager:
Production manager:
Has the FDA or DEA inspected the facility? If yes, provide dates and results.
DMF (or AADA) for drug substance:
Original file number:
Date:
Last DMF revision Date:
Reason:
A.
Strengths
1.
2.
3.
4.
5.
B.
Weaknesses
1.
2.
3.
4.
5.
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