GMP Audit Check List- Process Validation
GMP Audit Checklist – Process Validation
1. General Requirements
-
Validation Master Plan (VMP) available, approved, and up to date.
-
Validation activities aligned with regulatory guidelines (USFDA, EMA, WHO, ICH Q8–Q10).
-
Validation performed for all critical processes (manufacturing, cleaning, sterilization, packaging).
-
Risk assessment performed prior to validation.
2. Documentation
-
Approved protocols available (IQ, OQ, PQ, PPQ).
-
Validation reports complete, reviewed, and approved.
-
Deviations during validation documented and justified.
-
Change control procedures followed for modifications.
-
Data integrity principles (ALCOA+) followed in all records.
3. Equipment & Utilities
-
Equipment qualification (IQ/OQ/PQ) completed before process validation.
-
Calibration status of instruments verified and documented.
-
Utilities (HVAC, compressed air, purified water, WFI, steam) qualified and monitored.
-
Preventive maintenance program implemented for validated systems.
4. Manufacturing Process Validation
-
Critical process parameters (CPPs) identified and controlled.
-
Critical quality attributes (CQAs) established.
-
Process validation executed on commercial-scale equipment.
-
Minimum of 3 consecutive successful batches validated (or as per guideline).
-
Sampling plan, acceptance criteria, and statistical evaluation defined.
-
In-process and finished product testing performed and results trended.
5. Cleaning Validation
-
Cleaning validation performed for all product-contact equipment.
-
Acceptance criteria established (residual limits, swab/rinse testing).
-
Worst-case product selection justified.
-
Cleaning procedures documented in SOPs.
-
Cleaning validation revalidated after changes (product, equipment, process).
6. Analytical Method Validation
-
Methods validated as per ICH Q2 (Accuracy, Precision, Specificity, LOD, LOQ, Robustness).
-
Validation reports reviewed and approved by QA.
-
Transfer of validated methods documented.
-
Revalidation performed when method or equipment changes.
7. Continued/Ongoing Process Verification (CPV/OPV)
-
Ongoing monitoring of process trends (yield, impurities, dissolution, etc.).
-
Statistical process control charts maintained.
-
Annual product quality review (APQR/PQR) includes validation status.
-
Revalidation performed after major changes or failures.
8. Packaging Validation
-
Packaging process validated for integrity, labeling, serialization, and coding.
-
Transportation validation/shipping studies performed for product stability.
-
Tamper-evident and child-resistant packaging validated.
9. Revalidation
-
Triggers for revalidation defined (e.g., major equipment changes, facility modifications, critical deviations).
-
Periodic review of process validation performed.
-
Revalidation documented and approved by QA.
10. Compliance & Safety
-
Validation practices comply with cGMP and ICH guidelines.
-
Data integrity ensured in all validation records.
-
Audit trails enabled and reviewed for computerized systems.
-
SOPs available for validation planning, execution, and reporting.
✅ Key Audit Focus Points:
-
Validation Master Plan coverage.
-
Documentation of PPQ batches.
-
Compliance with data integrity in validation reports.
-
Ongoing process verification and trend analysis.
🎓 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.