Introduction
Internal audits and self-inspections are among the most powerful tools for maintaining GMP compliance.
Benefits include:
- Early gap identification
- Regulatory preparedness
- Continuous improvement
- Risk reduction
- Quality culture strengthening
This chapter provides practical audit checklists that can be adapted for:
- Internal Audits
- Supplier Audits
- Self-Inspections
- Mock FDA Inspections
- WHO Inspections
- EU GMP Inspections
- Customer Audits
SECTION A – GMP SYSTEM AUDIT CHECKLIST
Quality Management System
Documentation
□ Quality Manual available
□ Quality Policy approved
□ SOPs current and approved
□ Controlled document system established
□ Revision history maintained
□ Obsolete documents removed
Change Control
□ Change Control SOP available
□ Changes assessed for impact
□ Risk assessments documented
□ Validation impact evaluated
□ Effectiveness verified
CAPA System
□ CAPA procedure approved
□ Root causes scientifically identified
□ CAPAs implemented on time
□ CAPA effectiveness verified
□ Recurrence monitored
SECTION B – DEVIATION MANAGEMENT AUDIT
Deviation System
□ Deviations documented promptly
□ Classification justified
□ Product impact assessed
□ Root cause identified
□ CAPA implemented
□ Closure timely
Investigation Quality
□ 5 Why analysis performed
□ Fishbone used where appropriate
□ Evidence documented
□ Conclusions scientifically justified
SECTION C – DATA INTEGRITY AUDIT
ALCOA+ Compliance
□ Data attributable
□ Data legible
□ Data contemporaneous
□ Data original
□ Data accurate
□ Data complete
□ Data consistent
□ Data enduring
□ Data available
Electronic Systems
□ Unique usernames assigned
□ Password controls active
□ Audit trails enabled
□ Audit trails reviewed
□ Backup procedures validated
□ Access rights controlled
SECTION D – TRAINING SYSTEM AUDIT
Personnel Training
□ GMP training completed
□ SOP training current
□ Role-specific training completed
□ Training effectiveness evaluated
□ Competency assessments performed
Training Records
□ Records available
□ Attendance documented
□ Assessments retained
□ Retraining completed when required
SECTION E – PRODUCTION AUDIT
Documentation
□ BMR available
□ Entries contemporaneous
□ Corrections GDP compliant
□ Signatures complete
□ Line clearance documented
Manufacturing Controls
□ Equipment cleaned
□ Equipment status labeled
□ Materials identified
□ Process parameters monitored
□ IPC records complete
SECTION F – QUALITY CONTROL AUDIT
Laboratory Controls
□ Specifications approved
□ Methods validated
□ System suitability documented
□ Instrument calibration current
□ Standards qualified
OOS Program
□ OOS investigations timely
□ Root causes documented
□ Product impact assessed
□ Trending performed
SECTION G – VALIDATION AUDIT
Validation Program
□ VMP current
□ Validation schedule maintained
□ IQ/OQ/PQ complete
□ Reports approved
□ Revalidation current
Cleaning Validation
□ Worst-case products justified
□ Sampling methods validated
□ Acceptance criteria approved
□ Validation reports available
SECTION H – HVAC & CLEANROOM AUDIT
HVAC Controls
□ Differential pressures monitored
□ Temperature controlled
□ Humidity controlled
□ HEPA integrity current
□ Alarm systems functional
Cleanroom Controls
□ Cleaning records complete
□ Environmental monitoring current
□ Smoke studies available
□ Recovery studies completed
SECTION I – WATER SYSTEM AUDIT
Water System
□ Qualification current
□ Conductivity compliant
□ TOC compliant
□ Microbial limits met
□ Endotoxin monitoring current
Distribution Loop
□ No dead legs identified
□ Sanitization performed
□ Trend analysis reviewed
□ Excursions investigated
SECTION J – WAREHOUSE AUDIT
Material Management
□ FEFO followed
□ Quarantine status maintained
□ Released materials identified
□ Rejected materials segregated
Storage Conditions
□ Temperature monitored
□ Humidity monitored
□ Alarm systems functional
□ Mapping studies available
SECTION K – STERILE MANUFACTURING AUDIT
Personnel Qualification
□ Gowning qualification current
□ Media fill participation current
□ Training current
□ Monitoring records available
Environmental Monitoring
□ Viable monitoring current
□ Particle monitoring current
□ Trending performed
□ Excursions investigated
Media Fill Program
□ Worst-case conditions included
□ Interventions representative
□ Acceptance criteria met
□ Reports approved
SECTION L – SUPPLIER QUALITY AUDIT
Supplier Qualification
□ Supplier approved
□ Audit completed
□ Risk assessment performed
□ Quality Agreement active
Performance Monitoring
□ Supplier scorecards available
□ Complaints reviewed
□ CAPAs monitored
□ Requalification current
FDA INSPECTION READINESS CHECKLIST
Documentation Readiness
□ SOPs readily accessible
□ Validation reports available
□ Batch records complete
□ Training records available
□ Audit trail reviews current
Personnel Readiness
□ Employees understand procedures
□ Employees understand GMP
□ Interview coaching completed
□ Escalation process understood
Management Readiness
□ Quality metrics available
□ APQR current
□ CAPA effectiveness reviewed
□ Management Review completed
WHO / EU GMP INSPECTION CHECKLIST
□ CCS documented
□ Risk assessments available
□ Validation lifecycle demonstrated
□ Data Integrity controls effective
□ Environmental Monitoring robust
□ Contamination Control Strategy implemented
□ Change Control effective
□ QRM integrated
AUDIT OBSERVATION CLASSIFICATION
Critical Observation
Potential patient safety risk.
Examples:
- Data falsification
- Sterility assurance failure
- Product contamination
Major Observation
Significant GMP weakness.
Examples:
- Inadequate investigations
- Missing validation
Minor Observation
Limited compliance impact.
Examples:
- Documentation deficiencies
- Isolated procedural gaps
AUDIT EFFECTIVENESS METRICS
Organizations should monitor: