Saturday, October 20, 2012

Deviations & CAPA remains hot topic in Audits

MHRA Publishes set of information from its database summarizing their observations to show deviations and CAPA remains the hot topic for inspectors during their regular GMP inspections.

While investigations of anomalies (deviations, OOS, OOTs) remains at the top, insufficient CAPA comes at third position.

MHRA has come forward to publish some of the reasons for this continuous concern over the years. These questions and relevant answers give a good overview and tips on how EU inspectors review QRM elements from ICH Q9 and Q10 and how do they enforce them.

The details presentation can be downloaded at, click here

The tips and frequently asked questions regarding inspectors approach towards QRM can be downloaded, click here

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