Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
Attachment Vh
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
CHECKLIST FOR BATCH DOCUMENTS REVIEW
MARKET COMPLAINT
Ready to Fill Syringes
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 record for machine parts, filters,
and gowns
6. Area/equipment clearance (manufacturing)
7. Filter integrity test report
8. Printouts for leak test performed in autoclave
9. Area/equipment clearance (visual inspection)
10. Visual inspection request from production
Reviewed by:
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