Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
Attachment Vb
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
CHECKLIST FOR BATCH DOCUMENTS REVIEW
MARKET COMPLAINT
Powder-Filled Ampoules
Product:
Code No.:
Batch No.:
MANUFACTURING
Production
1. Raw material weighing record
2. Weighing print outs
3. Drug weighing area/equipment clearance
check list
4. Temperature and pressure differential records
5. Master formula and method
6. Manufacturing record No. 1
7. Sterilization record for machine parts, filters,
and gowns
8. Vials washing and sterilization records
9. Area/equipment clearance (manufacturing)
10. Area/equipment clearance (visual inspection)
11. Visual inspection request from production
Reviewed by:
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