The legal basis for APIs for the EU market to be manufactured under GMP — a requirement already in place in the US since the 1970s — was created through a directive adopted in March 2004. Health authorities in the EU are now gradually increasing their enforcement efforts and are training their inspectors to check for GMP compliance of APIs used in medicines marketed in the EU. In November 2006, a majority in the EU Parliament voted in favour of an important ‘Written Declaration’ that proposes that only GMP-certified APIs will be allowed in EU medicines.
Article / Jun 01, 2007
Enforcing GMP compliance for APIs in EU medicines
Pharmaceutical Technology Europe, June 2007