Audit tips in the pharmaceutical industry
A Good Manufacturing Practice (GMP) audit checklist in the
pharmaceutical industry ensures compliance with regulatory standards such as
those set by the FDA, EMA, WHO, or PIC/S. Here's a comprehensive GMP audit
checklist, organized by major sections:
1. General Facility Requirements
Cleanliness and maintenance of premises
Controlled access to production areas
Adequate space for orderly placement of equipment and materials
Proper lighting, ventilation, and environmental controls
Pest control measures in place
2. Personnel
Validated training program for GMP and job-specific roles
Health and hygiene policies followed
Protective clothing used correctly
Personnel access restricted to authorized areas
3. Documentation and Records
Standard Operating Procedures (SOPs) in place and current
Batch manufacturing records complete and accurate
Deviations and change control documented
Audit trail in electronic systems maintained
4. Equipment
Qualification and validation (IQ, OQ, PQ) documented
Calibration and maintenance logs up to date
Cleaning procedures defined and verified
Equipment labeled with status (clean/in use/out of order)
5. Materials Management
Approved vendor list available
Materials stored under appropriate conditions
Inventory control and stock rotation systems in place
Quarantine, approved, and rejected materials clearly labeled
6. Production Controls
Batch records reviewed and approved
In-process checks documented
Line clearance procedures followed
Cross-contamination controls implemented
7. Quality Control (QC)
Specifications and testing procedures defined
Laboratory instruments calibrated and maintained
Data integrity practices enforced
Out of Specification (OOS) procedures followed
8. Validation
Process validation protocols and reports available
Cleaning validation performed
Analytical method validation documented
Revalidation scheduled appropriately
9. Packaging and Labeling
Labels reconciled and stored securely
Packaging materials verified and checked
Tamper-evident features inspected
Final product labeling checked against approved artwork
10. Complaints and Recalls
Complaint handling procedure documented
Investigations conducted and CAPAs implemented
Recall procedures tested periodically
11. Self-Inspection and Internal Audits
Regular internal audits scheduled and documented
Findings tracked and corrected
Continuous improvement culture promoted
12. Warehousing and Distribution
Storage conditions monitored
FIFO (First-In, First-Out) or FEFO (First-Expiry, First-Out) used
Transportation conditions validated (e.g., cold chain)
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