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:

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

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

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Filesize: 2,84 MB

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