Complete Audit Checklist for Pharmaceutical Quality Assurance

Quality Assurance (QA) audits are essential to ensure pharmaceutical products are safe, effective, and compliant with Good Manufacturing Practices (GMP). A structured audit checklist helps organizations identify gaps, maintain compliance, and continuously improve quality systems.

This audit checklist can be used for internal audits, supplier audits, and regulatory inspections.

1. Quality Management System (QMS)

• Is a documented Quality Policy approved by management?

• Is a Quality Manual available and up to date?

• Are roles and responsibilities clearly defined?

• Does QA operate independently from Production?

• Are management review meetings conducted regularly?

• Are quality objectives defined and monitored?

• Is an effective change control system in place?

2. Documentation and Data Integrity

• Are SOPs controlled, approved, and periodically reviewed?

• Are Good Documentation Practices (GDP) followed?

• Are electronic records compliant with ALCOA+ principles?

• Are audit trails enabled and reviewed?

• Is document version control maintained?

• Are obsolete documents promptly removed from use?

3. Training and Personnel

• Is a training matrix available for all employees?

• Is GMP training conducted regularly?

• Are job-specific and SOP-based trainings documented?

• Is training effectiveness evaluated?

• Are personnel qualified for their assigned roles?

• Are hygiene and gowning procedures followed?

4. Premises and Utilities

• Is the facility design suitable for the products manufactured?

• Is proper segregation maintained to prevent contamination?

• Are HVAC systems qualified and monitored?

• Are water systems (PW/WFI) validated?

• Are cleaning and sanitation procedures defined?

• Is an environmental monitoring program in place?

5. Equipment and Computerized Systems

• Are equipment IQ/OQ/PQ completed?

• Is a calibration and preventive maintenance program in place?

• Are equipment logbooks maintained correctly?

• Is equipment status clearly labeled?

• Are computerized systems validated (CSV)?

6. Materials Management

• Is an approved vendor list maintained?

• Are suppliers qualified and periodically evaluated?

• Are raw materials sampled and tested as per SOPs?

• Are materials properly labeled (quarantine, approved, rejected)?

• Are storage conditions controlled and monitored?

• Is FIFO/FEFO followed?

7. Production and Process Controls

• Are Master Batch Records approved by QA?

• Are Batch Manufacturing Records completed accurately?

• Are line clearance procedures followed?

• Are in-process controls defined and monitored?

• Are deviations documented and investigated?

• Are reprocessing and rework activities approved?

8. Packaging and Labeling Controls

• Are packaging instructions approved?

• Are printed packaging materials controlled?

• Is label reconciliation performed?

• Are line clearance checks documented?

• Are tamper-evident features verified?

9. Quality Control (QC)

• Are analytical methods validated?

• Is a stability study program implemented?

• Are OOS and OOT results investigated?

• Are reference standards qualified?

• Is sample retention performed as per SOP?

10. Deviations, CAPA, and Change Management

• Is there a deviation management system?

• Is root cause analysis performed?

• Are CAPAs implemented and tracked?

• Is CAPA effectiveness evaluated?

• Are changes assessed for quality and regulatory impact?

11. Complaints, Recalls, and Pharmacovigilance

• Is a complaint handling system established?

• Are complaints trended and reviewed?

• Is a recall procedure defined and tested?

• Are mock recalls conducted?

• Are adverse events reported to authorities as required?

12. Validation and Qualification

• Is a Validation Master Plan (VMP) available?

• Are processes and cleaning procedures validated?

• Are analytical methods validated?

• Are hold time and transport validations performed?

13. Self-Inspection and Audits

• Is an internal audit program established?

• Are audits conducted as per schedule?

• Are audit observations documented?

• Are corrective actions tracked and closed?

14. Quality Risk Management

• Is Quality Risk Management (ICH Q9) implemented?

• Are risks identified and documented?

• Are mitigation measures applied and reviewed?

15. Regulatory Compliance

• Are product licenses and approvals current?

• Are regulatory commitments tracked?

• Are Annual Product Quality Reviews (APQR/PQR) conducted?

• Is inspection readiness maintained?

Conclusion

A well-structured QA audit checklist helps pharmaceutical organizations identify risks early, strengthen compliance, and ensure consistent product quality. Regular audits not only support regulatory requirements but also promote a strong quality culture.