Checklist for Internal Audit or Self Inspection Defects and Regulatory Compliance
🏭 Checklist for Internal Audit / Self-Inspection
(Defects & Regulatory Compliance)
1. Documentation & Data Integrity
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✅ Are records complete, contemporaneous, and accurate (ALCOA+ principles)?
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✅ Any overwriting, missing data, or backdated entries?
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✅ Are controlled copies of SOPs in use (no obsolete versions)?
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✅ Are audit trails enabled and reviewed for computerized systems?
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✅ Is there evidence of data falsification or manipulation?
Common Defects: Incomplete entries, undocumented corrections, uncontrolled SOPs, shared logins.
2. Quality Systems (QMS)
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✅ Are deviations, OOS, and OOT properly investigated with root cause analysis?
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✅ Are CAPAs implemented and effectiveness verified?
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✅ Are change controls documented and risk-assessed?
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✅ Are complaint and recall procedures established and tested?
Common Defects: Superficial investigations, recurring deviations, ineffective CAPAs.
3. Personnel & Training
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✅ Are job descriptions and responsibilities clearly defined?
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✅ Are training records complete, role-specific, and up to date?
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✅ Is GMP training provided periodically?
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✅ Are medical fitness certificates available for all staff?
Common Defects: Untrained staff, missing training effectiveness checks, expired medical certificates.
4. Premises & Facilities
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✅ Are production, warehouse, and QC areas clean, organized, and pest-free?
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✅ Is HVAC validated and differential pressure maintained?
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✅ Are water and utility systems qualified and monitored?
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✅ Are change rooms and gowning areas adequate and compliant?
Common Defects: Poor housekeeping, inadequate segregation, pressure differentials out of limit.
5. Equipment & Instruments
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✅ Are equipment calibrated, qualified, and maintained as per schedule?
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✅ Are “Cleaned / In-use / To be cleaned” status labels used?
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✅ Are logbooks maintained properly?
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✅ Are balances and instruments checked daily before use?
Common Defects: Use of uncalibrated equipment, incomplete logbooks, drift in balances.
6. Materials Management
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✅ Are starting materials stored under recommended conditions?
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✅ Are materials labeled with proper status (Quarantine, Released, Rejected)?
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✅ Are expired or rejected materials segregated?
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✅ Is FIFO/FEFO system implemented?
Common Defects: Mix-ups, missing status labels, poor segregation, expired material in storage.
7. Production & In-Process Controls
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✅ Are BMRs/BPRs complete and reviewed?
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✅ Is line clearance done and documented before each batch?
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✅ Are in-process checks documented and within limits?
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✅ Is cross-contamination prevented by design and SOPs?
Common Defects: Missing signatures, incomplete entries, inadequate line clearance.
8. Laboratory Controls
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✅ Are test methods validated and current?
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✅ Are raw data and chromatograms retained and reviewed?
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✅ Are out-of-trend (OOT) results investigated?
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✅ Are reagents, standards, and solutions labeled with preparation/expiry dates?
Common Defects: Missing raw data, expired reagents, incomplete investigations, selective reporting.
9. Distribution & Complaints
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✅ Are distribution records traceable to batch numbers?
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✅ Are transportation/storage conditions monitored?
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✅ Are complaints investigated and trended?
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✅ Is recall procedure tested periodically?
Common Defects: Poor traceability, no cold-chain validation, incomplete complaint investigations.
10. Regulatory Compliance & Governance
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✅ Are regulatory filings aligned with current practices?
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✅ Are commitments from previous inspections fulfilled?
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✅ Are internal audits conducted at defined frequency?
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✅ Are management reviews documented with follow-up actions?
Common Defects: Repeat audit findings, unimplemented commitments, lack of follow-up.
📌 Quick Self-Inspection Focus
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Documentation gaps
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Equipment calibration/maintenance
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Training compliance
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CAPA effectiveness
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Storage & segregation of materials
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Data integrity & traceability
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