Praxisnahe Umsetzung von GMP-Anforderungen in der Hilfsstoffherstellung
gempex GmbH, Mannheim
Requirements for Good Manufacturing Practices (GMP) regarding the production of pharmaceutical excipients already exist for several years. They are laid down in rules of the WHO, in a supplement of the American pharmacopoeia (USP), and in industry standards like the one of the IPEC (International Pharmaceutical Excipients Council, The Joint IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, 2006). Although it is clear that such requirements need to be defined it has not yet been possible to fix them in legally binding regulations as it was shown recently by the unsuccessful effort to implement “GMP for Excipients” based on a European directive. The reason for this and what exactly is the difficulty in the application and realization of such GMP regulations will be discussed in the following article. Also it will be pointed out what is specific for excipients and the related production facilities, the specific quality related requirements, and how to fulfill those requirements. Additionally the GMP starting point, the meaning of a risk assessment as well as the coexistence of GMP in parallel with non-GMP production will be part of the discussions within the article.
pharmind 2010, Nr. 3, Seite 428