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-2019Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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