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 document 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 the draft document also covers the competency and quality requirements for third party auditors, based on ISO guidelines 19011 and 17021 respectively.
Project leader Iain Moore, a QA specialist at Croda, told in-Pharmatechnologist.com that, in terms of feedback, this team is looking a thoughtful examination of Excipact’s likely impact on supplier qualification.
“Where people have time we love to receive detailed comments on the actual requirements in the document, and the way we have written them. Are they clear and does the reader understand them?
Dr Moore also touched on “What we would like to limit in feedback is observations on formatting and so on as we will do that in a separate proof reading phase of the document development.”
The deadline for feedback is June 30th.
US FDA teams with IPEC
In related news the US Food and Drug Administration (FDA) has asked a team from IPEC Americas to help it develop a library of pharmaceutical excipients for use in future screening efforts.
The collaboration will see members of IPEC America’s qualification committee work with the FDA’s Division of Pharmaceutical Analysis (DPA) on creating the database.
IPEC said it “will be to assist FDA in surveillance of raw materials and finished products through rapid screening techniques to better identify materials in need of more in depth analysis - in order to prevent counterfeit, contaminated and mislabelled substances from entering the market and causing harm.”