The standards, known as Excipact, will be unveiled at the International Pharmaceutical Excipients Council Europe’s (IPEC - Europe) 20th anniversary celebrations in Barcelona, Spain on January 26, 2012 by representatives of the EFCG, the FECC and the PQD.
In a release on its website earlier IPEC said that: “Excipact has reached a critical point, and we are now working very hard on delivering the scheme for industry to begin using in the New Year.
“We are finalising the standards, but have to remain synchronised with the ANSI-NSF 363 standard (which is Excipact for organisations without ISO 9001) – especially as the current review involves feedback from the US Food and Drug Administration.”
The organisation also said it has met with third-party audit organisations and various auditor training organisations adding that it is developing legal agreements with them, the auditor registration scheme and is working on scheduling dates for the first auditor training session.
Background
In-Pharmatechnologist.com spoke with Excipact project director Ian Moore, a QA specialist at specialty chemicals firm Croda when the second draft of the document was released for comments in May this year.
He explained that Excipact is intended to give suppliers, users and auditors manufacturing and distribution standards that ensure product quality and minimise the regulatory burden such firms face under new rules being debated in Europe and the US.
“With proposed legislation requiring GMP and GDP for excipients in Europe and the USA, excipient suppliers will be faced with an avalanche of customer and customer-led third party audits to ensure they and their products meet these new requirements.”
Excipact, which uses ISO 9001 as a framework, consists of two annexes covering good manufacturing and distribution practice (GMP/GDP) that can be used to assess excipient suppliers and distributors.
In addition it also covers the competency and quality requirements for third party auditors, based on ISO guidelines 19011 and 17021 respectively.