GMP audit requirements
Anil Pareek
Popular
Core Audit Categories
GMP audits assess these primary areas, with auditors reviewing records, observing operations, and interviewing staff:
- Quality Management System (QMS): Policies, SOPs, CAPA, deviation handling, change control, and internal audits.
- Personnel: Training records, hygiene practices, gowning, health monitoring, and role qualifications.
- Facilities and Equipment: Design, maintenance, cleaning validation, calibration, and environmental controls (e.g., HVAC, pest control).
- Documentation and Records: Batch records (BMR/BPR), stability data, lab notebooks, and electronic systems compliance (ALCOA+).
Process and Material Controls
Auditors verify controls at each manufacturing stage to prevent contamination and ensure consistency:
- Raw Materials and Suppliers: Qualification, testing, receipt, storage, and inventory management (FIFO).
- Production Processes: Process validation, in-process controls, weighing, mixing, and equipment use.
- Packaging and Labeling: Material verification, line clearance, and reconciliation.
- Quality Control Laboratory: Analytical methods, equipment qualification, OOS investigations, and data integrity.
Additional Compliance Areas
These elements address post-production and risk management:
- Sanitation and Hygiene: Cleaning schedules, sanitization validation, waste disposal, and cross-contamination prevention.
- Warehousing and Distribution: Segregation, temperature mapping, stock rotation, and shipment records.
- Complaints, Recalls, and Stability: Investigation procedures, mock recalls, and APQR (Annual Product Quality Review).
- Validation and Audits: Prospective/retrospective validation, computer system validation, and supplier audits.