Liquid Production Audit Checklist

1. Facility & Environment

• Production area designed as per GMP (segregated zones, unidirectional flow).

• Cleaning and sanitization records of manufacturing & filling areas available.

• Air Handling Units (AHUs) qualification and filter integrity test records.

• Temperature, humidity, and differential pressure monitoring records.

• Pest control records for production area.

2. Equipment & Utilities

• Equipment qualification (IQ/OQ/PQ) records available.

• Preventive maintenance and calibration records updated.

• Cleaning and line clearance documented before and after use.

• Purified Water (PW) / Water for Injection (WFI) system validation and monitoring records.

• Utilities (compressed air, nitrogen, steam) quality monitored.

3. Raw Material Handling

• Dispensing done in controlled environment with line clearance.

• Materials issued as per approved batch manufacturing record (BMR).

• Raw materials properly labeled (Quarantine/Approved/Rejected).

• Balances calibrated and used with logs.

4. Manufacturing Process

• BMR available, approved, and followed step-by-step.

• In-process checks (pH, viscosity, volume, weight, clarity) recorded.

• Mixing time, temperature, and speed documented.

• Control over addition of active pharmaceutical ingredients (APIs) and excipients.

• Cross-contamination prevention measures implemented.

5. Filtration & Filling

• Filtration records (filter integrity test, sterilization records if sterile liquids).

• Filling area classified and maintained (Grade A/B if sterile).

• Line clearance before filling documented.

• Volume/weight checks during filling documented.

• Container/closure integrity checks performed.

6. Packaging & Labeling

• Labels reconciled and controlled under SOP.

• Packaging line clearance records available.

• Verification of correct batch coding and expiry date.

• Container integrity (leak test, torque test for bottles) performed.

7. Documentation & Record Keeping

• Master Formula Records (MFR) and BMR controlled.

• Logbooks of equipment updated contemporaneously.

• Deviations/OOS/OOT properly documented and investigated.

• Yield reconciliation performed at every stage.

• Batch release only by QA approval.

8. Personnel & Training

• Gowning procedures followed and monitored.

• Training records available for operators and supervisors.

• Personnel hygiene monitored (medical checks, health status).

• Access control for sensitive areas (filling, sterile production).

9. Quality Control Integration

• In-process samples tested and results available.

• Finished product testing records available before batch release.

• Retention samples stored properly.

• Stability samples pulled and tested as per stability protocol.

10. Safety & Compliance

• MSDS available for all raw materials and solvents.

• Spill management SOPs in place.

• Fire safety and emergency exits available and accessible.

• Compliance with GMP, WHO, USFDA, EMA, and local regulations.

🎓 Discover one of the best Complete Pharmaceutical Quality Assurance Course available —click below to explore the course that’s shaping future in QA Course skills.

https://trcjw.on-app.in/app/oc/306166/trcjw?utm_source%3Dcopy-link%26utm_medium%3Dtutor-course-referral%26utm_campaign%3Dcourse-overview-app