Privatsphäre-Einstellungen

GMP-Beanstandungen bei Inspektionen von pharmazeutischen Herstellbetrieben in den USA, in Europa und in der Schweiz

Schwerpunkt: Validierung/Qualifizierung

Beatrice A. Harder a , Hansruedi Siegrist b und Jost Wiederkehr c

The R. W. Johnson Pharmaceutical Research Institute, A Division of Cilag AG a , Schaffhausen, Novartis Animal Health Inc.b , Basel, und Bundesamt für Gesundheit c , Bern (Schweiz)

GMP Deficiencies from Inspections of Pharmaceutical Manufacturing Plants in USA, Europe and Switzerland /Focus: validation /qualification

Inspections of pharmaceutical companies lead to the identification of a number of GMP deficiencies every year. Due to the Freedom of Information Act, many more inspection data are published in the USA than in Europe. Collection of inspection data and statistical analysis thereof is critically discussed in this article and categories of the most frequently cited GMP deficiencies are identified. Deficiencies related to validation/ qualification receive very often top rankings in statistics. Therefore the terms „qualification“ and „validation“ are discussed in more detail and various relevant official guidelines are referenced. Companies may use inspection data to improve their own GMP compliance as well as to analyse trends in view of potential future inspection topics. For the regulatory/inspection authorities, data collection may be a useful tool for establishing a classification and categorisation of GMP deficiencies in order to identify general weak spots in the area of GMP compliance and to compare the level of compliance between companies.

Key words Beanstandungen · GMP-Compliance · Inspektionen · Pharmazeutische Herstellbetriebe · Qualifizierung · Validierung