Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
Attachment Ve
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
CHECKLIST FOR BATCH DOCUMENTS REVIEW
MARKET COMPLAINT
Lyophilized products
Product:
Code No.:
Batch No.:
MANUFACTURING
Production
Check the:
1. Raw material weighing record
2. Temperature and pressure differential records
3. Master formula and method
4. Manufacturing record
5. Sterilization cycle chart
6. Vials washing and sterilization records
7. Lyophilization cycle chart
8. Area/equipment clearance (manufacturing)
9. Filter integrity test report
10. Area/equipment clearance (visual inspection)
11. Visual inspection request from production
Reviewed by:
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