GMP (Good Manufacturing Practices) rules for the pharmaceutical industry are layed down in numerous laws, regulations, guidelines and standards – with different international peculiarity…
Standardization is the final goal. But what is the actual status of the efforts of the international organizations? "GMP requirements are now largely harmonised and there are no differences - can this statement be true?"
Raimund Brett, Principal Consultant of gempex, addresses this question in an expert opinion of phpro 03/2020. Keywords from the article are EU-US Sectoral Annex for Pharmaceutical GMP, MRA (Mutal Recognition Agreement), FDA, inspections for compliance with cGMPs. The article provides insights into the practice and names factors for a successfull completed inspection.
The German language article is available for download at www.gempex.com/GMP-Knowledge.
gempex wishes you an interesting reading!
If you would like to get in contact with the author please send an inquiry to info@gempex.com.