SELF INSPECTION CHECKLIST FOR QA
- Sampling procedure of intermediate / finished products and control sample
- Line clearance procedure
- Review of online batch records for checking of in-process results
- Handling of Batch record system Procedure
- DISPOSAL OF INPROCESS TEST SAMPLE
DOCUMENT CONTROL:
Authorization, issuance and control of
Following documents
- SOP’S
- Specifications and testing procedures,
- Validation documents
- BMR/BPR
Document distribution records
Change control procedure
Deviation control procedure
Filing and storage of completed batch records
Filing and storage of master documents and superseded documents
VALIDATION:
- Master validation plan (VMP)
- Cleaning validation protocols
- Validation protocols and reports for critical equipment’s of different areas
- Process Validation protocol and report
- Retrospective validation protocol and report
- Validation protocol and reports for air handling system of different areas
- Validation protocols and records for water system
Other :
- Market complaint handling procedure and records thereof
- Product recall / Mock Recall Procedure
- Reports of supplier / third party inspections
- Self- inspection reports (previous) and their follow up
- Subcontractor Quality inspection