The second draft of Excipact, a set of certification standards for drug excipient producers being developed by the EFCG, FECC, IPEC and PQD, has been sent to industry stakeholders for consultation.
The guidelines are intended to give industry suppliers, users and auditors the manufacturing and distribution criteria that will help ensure product quality and minimize the regulatory burden they face under the new rules proposed in Europe and the US.
Excipact uses ISO 9001 as a framework, and consists of two annexes covering good manufacturing and distribution practice (GMP/GDP) that can be used to assess excipient suppliers and distributors. With proposed legislation requiring GMP and GDP for excipients in Europe and the USA, it is expected that excipient suppliers will be faced with a deluge of audit requests.
June 30th is the feedback deadline.
Posted by Bruce Lehr May 2nd 2011.