Internal Audit / Self-Inspection Checklist

(Defects & Regulatory Compliance Focus)

1. Documentation & Records

• Are SOPs, policies, and work instructions up-to-date, approved, and controlled?

• Is there evidence of uncontrolled or obsolete documents in use?

• Are logbooks, batch records, and test records filled in contemporaneously and error-free?

• Are corrections made according to GDP practices (no overwriting, signed & dated)?

• Are audit trails reviewed regularly (for computerized systems)?

2. Deviations, OOS, and CAPA

• Are all deviations/OOS/OOT properly documented, investigated, and closed on time?

• Are root cause investigations scientifically sound (not superficial)?

• Is there evidence of repeat deviations without effective CAPA?

• Are CAPAs tracked and verified for effectiveness?

• Are regulatory timelines for reporting (if applicable) followed?

3. Training & Personnel

• Are personnel qualified and trained for their roles?

• Are training records complete, current, and periodically evaluated?

• Is there evidence of gaps in GMP knowledge during interviews?

• Are hygiene practices (gowning, handwashing) followed correctly?

4. Equipment & Instruments

• Are equipment calibrated, qualified, and maintained per schedule?

• Are defective or “out of service” equipment clearly labeled?

• Are cleaning and maintenance logs properly recorded?

• Are balances, HPLC, GC, etc. subject to routine performance checks?

5. Facilities & Environment

• Are premises clean, orderly, and free of defects (leaks, cracks, rust, dust)?

• Are classified areas monitored for temperature, humidity, pressure differentials, particle counts?

• Is there evidence of pest control in place?

• Are utilities (HVAC, water system, compressed air) validated and monitored?

6. Production & Packaging

• Are line clearance procedures followed and documented?

• Is there evidence of mix-ups, mislabeling, or poor reconciliation?

• Are in-process controls and yields within acceptable limits?

• Is data recorded contemporaneously during manufacturing and packaging?

7. Quality Control (QC)

• Are laboratory practices compliant with GLP & ALCOA+ principles?

• Are reference standards, reagents, and solutions properly stored and labeled?

• Are sample handling, labeling, and storage practices compliant?

• Are test results, chromatograms, and spectra reviewed properly (including raw data)?

• Is there evidence of data manipulation, falsification, or backdating?

8. Supplier & Materials Management

• Are suppliers/vendor qualifications documented and current?

• Are starting materials and packaging materials quarantined, tested, and released properly?

• Is there traceability of materials from receipt to use?

• Are rejected materials handled according to SOPs?

9. Regulatory Compliance

• Are annual product quality reviews (APQR/APR) conducted and documented?

• Are regulatory commitments (variations, renewals, responses to agencies) up to date?

• Is there compliance with local & international GMP guidelines (FDA, EMA, WHO, PIC/S)?

• Are recent inspection findings and internal audits addressed effectively?

10. Data Integrity

• Are systems compliant with 21 CFR Part 11 / Annex 11 (for electronic data)?

• Is there any evidence of uncontrolled user access?

• Are audit trails periodically reviewed and documented?

• Are raw data securely stored and retrievable?

✅ Purpose of Checklist: To identify defects, gaps, or non-compliances before regulatory inspections and to ensure a state of control across all GMP systems.

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