Gmp Audit Checklist

Quality Management System

□ Quality manual current and complete
□ SOPs comprehensive and current
□ Document control system effective
□ Change control procedures followed
□ Training program documented
□ Management review conducted
□ Quality objectives defined
□ Risk management implemented
□ CAPA system functioning
□ Internal audit program active
□ Supplier qualification maintained
□ Customer complaint handling effective

Personnel & Training

□ Organizational chart current
□ Job descriptions defined
□ Qualification requirements met
□ Training matrix maintained
□ Training records complete
□ Competency assessments done
□ GMP training provided
□ Hygiene training conducted
□ Safety training current
□ Visitor policies enforced
□ Health monitoring active
□ Personal protective equipment used

Facilities & Equipment

□ Facility design appropriate
□ Clean rooms classified properly
□ Environmental monitoring active
□ Temperature/humidity controlled
□ Air handling systems validated
□ Water systems qualified
□ Equipment qualified (IQ/OQ/PQ)
□ Preventive maintenance scheduled
□ Calibration program current
□ Cleaning validation complete
□ Pest control program effective
□ Waste management appropriate

Raw Materials & Components

□ Supplier approval process documented
□ Incoming inspection performed
□ Sampling plans appropriate
□ Testing procedures validated
□ Specifications defined
□ Certificate of analysis verified
□ Quarantine procedures followed
□ Release procedures documented
□ Storage conditions maintained
□ Inventory control effective
□ Expiry dating managed
□ Rejected material controlled

Production & Process Controls

□ Master batch records approved
□ Batch records complete
□ Process validation current
□ In-process controls defined
□ Critical parameters monitored
□ Deviations investigated
□ Line clearance performed
□ Equipment logs maintained
□ Yield calculations done
□ Reconciliation performed
□ Time limits established
□ Environmental conditions monitored

Laboratory Controls

□ Laboratory qualified
□ Test methods validated
□ Reference standards managed
□ Reagents controlled
□ Sample management effective
□ Testing timelines met
□ OOS investigations thorough
□ Stability program comprehensive
□ Retain samples stored
□ Data integrity ensured
□ Equipment calibrated
□ Training documented

Packaging & Labeling

□ Packaging components controlled
□ Label control procedures effective
□ Line clearance verified
□ Print verification performed
□ Coding equipment validated
□ Reconciliation conducted
□ Obsolete labels destroyed
□ Storage conditions appropriate
□ Gang printing prohibited
□ Version control maintained
□ Customer requirements met
□ Regulatory compliance ensured

Quality Control & Assurance

□ Specifications established
□ Sampling procedures defined
□ Testing procedures validated
□ Release criteria clear
□ Batch release authorized
□ Stability studies conducted
□ Trend analysis performed
□ Product quality reviews done
□ Change control assessed
□ Validation master plan current
□ Risk assessments conducted
□ Continuous improvement active

Documentation & Records

□ GDP (Good Documentation Practices) followed
□ Records contemporaneous
□ Data integrity maintained
□ Electronic records compliant (21 CFR Part 11)
□ Batch records reviewed
□ Deviations documented
□ Investigations thorough
□ Retention periods followed
□ Archive system secure
□ Audit trail maintained
□ Document retrieval efficient
□ Destruction procedures controlled

Validation & Qualification

□ Validation master plan current
□ Equipment qualification complete
□ Process validation performed
□ Cleaning validation done
□ Computer system validation current
□ Method validation complete
□ Revalidation scheduled
□ Change impact assessed
□ Protocols approved properly
□ Reports reviewed and approved
□ Deviations addressed
□ Acceptance criteria met

Warehouse & Distribution

□ Storage conditions maintained
□ Temperature mapping done
□ Monitoring systems calibrated
□ FIFO/FEFO practiced
□ Segregation areas defined
□ Security measures adequate
□ Shipping validation performed
□ Cold chain maintained
□ Distribution records complete
□ Returns handled properly
□ Recall procedures ready
□ Traceability ensured

Regulatory Compliance

□ Regulatory requirements identified
□ Licenses/permits current
□ Regulatory submissions timely
□ Inspection readiness maintained
□ Regulatory changes tracked
□ Commitments tracked
□ Compliance metrics monitored
□ Audit findings addressed
□ CAPA effectiveness verified
□ Management oversight active
□ Continuous improvement demonstrated
□ Best practices implemented