Saturday, 27 July 2019

EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018


A review of data from API inspections conducted by the EDQM between 2006 and 2018 is now available (PA/PH/CEP(18) 56 April 2019).

This document summarises the trends of deficiencies observed in EDQM inspections with reference to EU GMP and to the corresponding CEP dossiers.

This document is a review of data from API inspections conducted by the EDQM between 2006 and 2018. It covers: - the location of the inspections; - whether they were initial or re-inspections; - their outcome; - the distribution of the observed deficiencies to EU Good Manufacturing Practice (GMP) Part II area and criticality; - the frequency of the findings; - issues of data integrity.

For details, see: https://www.edqm.eu/en/news/edqm-inspections-and-trends-gmp-deficiencies-overview-2006-2018-paphcep18-56-april-2019

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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