Pharmaceutical Supplier GMP Audit Checklist

1. Quality Management System
Checklist Item Yes/No Remarks
Quality policy and objectives documented
Quality Manual available and current
Effective change control upheld
2. Personnel & Training
Checklist Item Yes/No Remarks
Organizational chart up-to-date
Training records maintained
GMP training provided to personnel
3. Premises & Equipment
Checklist Item Yes/No Remarks
Premises maintained and clean
Equipment calibrated and qualified
Cleaning records available
4. Documentation
Checklist Item Yes/No Remarks
All SOPs current and controlled
Records are legible and properly archived
5. Material Management
Checklist Item Yes/No Remarks
Approved supplier list maintained
Receipt, storage, and issuance controlled
Status of materials clearly identified
6. Production & In-Process Controls
Checklist Item Yes/No Remarks
Batch records maintained and complete
In-process controls monitored and recorded
7. Quality Control
Checklist Item Yes/No Remarks
QC laboratory adequately equipped
Testing procedures validated
8. Complaints & Recalls
Checklist Item Yes/No Remarks
Complaints handled and documented
Recall procedures established and effective
9. Self-Inspection & Continuous Improvement
Checklist Item Yes/No Remarks
Self-inspections conducted regularly
CAPAs implemented and tracked
Audit Summary / Comments