@FRD
Areas under FDA GMP (Good Manufacturing Practices) inspection:
1. Facility and Equipment
– Facility Design (layout, space, cleanliness)
– Equipment design, maintenance, calibration, and cleaning
– Utilities (qualification of water systems, HVAC, and other utilities critical to production)
2. Materials Management
– Proper sourcing, testing, and storage of raw materials
– Tracking and reconciliation of materials
– Supplier Qualification
3. Production and Process Controls
– Standard Operating Procedures (SOPs)
– Process Validation
– In-Process Controls
– Batch Records
4. Quality Control and Testing
– Adequate testing of raw materials, in-process materials, and finished products
– Established quality standards for materials and products
– Evidence that products remain within specifications throughout their shelf life
– Proper handling and investigation of OOS results
5. Packaging and Labeling
– Label Control
– Packaging Integrity
– Expiry Dating
6. Documentation and Recordkeeping
– Batch Records
– Deviations
– Change Control
– Training Records
7. Self-Inspection and Audits
– Internal Audits
– CAPA Managements
8. Complaint Handling and Recall Procedures
9. Data Integrity
– ALCOA+ Principles
– Electronic Records
10. Quality Risk Management (QRM)