GMP Inspection in the EU: Avoiding 12 Common Pitfalls
Drugmakers don’t want to see any of these observations after their next good manufacturing practice (GMP) inspection in the EU:
- Immature risk management
- Inadequate handling of deviations
- Inadequate handling of changes
- Insufficient maintenance of rooms
- Insufficient cleaning validation
- Insufficient process validation
- Insufficient traceability of the batch documentation
- Inadequate labeling of the status/usability of cleaning materials
- Insufficient consideration of electronic or hybrid data paths
- Insufficient instructions for handling out-of-specification (OOS) results
- Inadequate communication on decisions
- Insufficient traceability of complaints
GMP inspectors in the EU see the same noncompliance issues again and again. How can you avoid these common problems?
To successfully comply with EU GMPs, you must look beyond the surface of an issue — or potential problem — to identify its root cause and consider how it impacts all other aspects of operation.
For example, an inspector noted an incorrect batch number in a deviation report and saw that the manufacturer had attributed it to human error — an overly simplistic view in most situations. By not digging deep enough to see if there were technical or organizational causes contributing to the human error, the manufacturer missed an opportunity to take more comprehensive corrective and preventive measures. The errors kept occurring, keeping the manufacturer in a state of noncompliance.
Using case studies, GMP Inspections in the EU: Avoiding 12 Common Pitfalls analyzes where the drugmakers went wrong and provides recommendations to avoid the same pitfalls. Each case study notes the section of the EU GMP guide related to the violation. And for easy reference, the appendix includes a copy of the guide.
Key management report takeaways:
- Continuously updating risk analysis during the lifecycle of the process or equipment
- Conducting root cause and failure analyses
- Involving all relevant people in a change request
- Developing SOPs that cover all compliance issues
- Reconciling batch documentation
Noncompliance can be expensive. Learn from others’ mistakes before they become your problem.
Who Will Benefit
- Quality control unit
- Regulatory affairs
- Cleanroom maintenance staff
Add to Cart
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.