Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
Attachment Vf
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
CHECKLIST FOR BATCH DOCUMENTS REVIEW
MARKET COMPLAINT
Powder-Filled Vials
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 (MFM)
4. Manufacturing record
5. Sterilization record for machine parts, filters,
and gowns
6. Vials washing and sterilization records
7. Seals/stoppers sterilization records
8. Cramper sterilization record
9. Area/equipment clearance (manufacturing)
10. Area/equipment clearance (visual inspection)
11. Visual inspection request from production
Reviewed by:
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