Excipact auditing certification scheme explained

By Gareth Macdonald

- Last updated on GMT

April saw the publication of the second draft of Excipact, a set of certification standards for third-party auditors of excipient manufacturers.

The document​, which is being developed by the EFCG, FECC, IPEC and PQD, is intended to give suppliers, users and auditors manufacturing and distribution standards that ensure excipient quality

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.

Project co-ordinator Dr Iain Moore, from specialty chemicals firm Croda, told in-Pharmacetechnologist.com why such certification is necessary and how stakeholders can share their thoughts on the proposals.

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