Common GMP Inspection failure in 2015

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Common GMP inspection finding in recent years.


Laboratory controls


ü  Lack of or inadequate method validation,
ü  Online documentation,
ü  Scientific and appropriate specifications/analytical procedures; Failures of adequate investigations on out-of-specification (OOS) and out-of trends (OOT);
ü  Failures of adequate stability testing programs to assess the Quality attributes.

Quality system

ü  Failure of the quality unit to release/reject APIs,
ü  Scrutinized review of quality-related documents;
ü  failure in investigations,
ü  Quality reviews of the APIs and handling of APIs CMC changes.

Equipments

ü  Maintenance,
ü  Cleaning procedures,
ü  Validation of cleaning procedures,
ü  Cleaning,
ü  Store and sanitization for contamination or carryover.

Records and reports

ü  Failures in batch records preparation;
ü  Establishment of written procedures related to production, Quality,
ü  Laboratory controls, and
ü  Material management.



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