Frequent Deficiencies in GMP Inspections

Excerpt from the GMP Compliance Adviser

EU GMP inspectors see the same GMP deficiencies again and again. How can you avoid these common problems?

To successfully comply with GMP requirements, 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.

GMP inspector Lea Joos highlights 12 case studies from her inspection practice. Frequent Deficiencies in GMP Inspections analyzes where manufacturers 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.

The e-book discusses the following 12 deficiencies:

1. Immature risk management
2. Inadequate handling of deviations
3. Inadequate handling of changes
4. Insufficient maintenance of rooms
5. Insufficient cleaning validation
6. Insufficient process validation
7. Insufficient traceability of the batch documentation
8. Inadequate labeling of the status/usability of cleaning materials
9. Insufficient consideration of electronic or hybrid data paths
10. Insufficient instructions for handling out-of-specification (OOS) results
11. Inadequate communication on decisions
12. Insufficient traceability of complaints

Non-compliance can be expensive. Learn from others’ mistakes before they become your problem!