The FDA has published the 2024 Inspectional Observation Data Sets. I don’t think there are any surprise that on what the inspection observations data for fiscal year 2024 shows and what key GMP inspection themes emerge for drug manufacturers:
Quality Systems and Documentation
Inadequate Procedures and Documentation
- Failure to establish or follow written procedures for various operations, including quality control, production, and process controls.
- Lack of complete documentation for investigations, batch records, and laboratory testing.
Quality Control Unit Deficiencies
- Inadequate responsibilities and authority of the quality control unit.
- Failure to approve or reject components, products, procedures, or specifications.
Manufacturing and Process Controls
Equipment and Facility Issues
- Inadequate design, maintenance, or cleaning of manufacturing equipment.
- Deficiencies in facility maintenance, sanitation, and environmental controls.
Process Validation and Control
- Lack of adequate process validation, especially for sterile drug products.
- Insufficient control procedures to monitor and validate manufacturing processes.
Laboratory Controls
Inadequate Laboratory Practices
- Failure to establish scientifically sound laboratory controls.
- Deficiencies in test methods validation and stability testing programs.
Component Testing
- Inadequate testing of drug components and reliance on supplier certificates without proper verification.
Sterile Drug Manufacturing
Aseptic Processing Deficiencies
- Inadequate procedures and validation for sterile drug products.
- Deficiencies in environmental monitoring and control systems for aseptic processing areas.
Training and Personnel
Inadequate Employee Training
- Insufficient training of employees in GMP and specific job function.
Complaint Handling and Product Quality Reviews
Deficient Complaint Procedures
- Inadequate procedures for handling product complaints.
Annual Product Quality Review
- Failure to conduct adequate annual product quality reviews.
Equipment Related
Out of the 365 observations that mention equipment, 277 are from just 5 regulations. Let’s take a deeper look.
| Reference Number | Short Description | Long Description | Frequency |
|---|---|---|---|
| 21 CFR 211.63 | Equipment Design, Size and Location | Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance]. Specifically, *** | 85 |
| 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance | Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, *** | 76 |
| 21 CFR 211.67(b) | Written procedures not established/followed | Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, *** | 60 |
| 21 CFR 211.68(a) | Calibration/Inspection/Checking not done | Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, *** | 30 |
Improper design and qualification, improper cleaning, improper calibration and inspections. Yes these take work, but these are all areas that effort can improve.
Investigations of a Dog 