IPEC e-newsletter - Excipients Insight June/July 2017 - 10-07-17


Inside this issue


Q&RA committee update

The Quality & Regulatory Affairs Committee covered a large amount of ground at its latest meeting on 1 June, including progress with the revision of the IPEC Quality Agreement guide, which is being carried out by IPEC Europe in collaboration with IPEC-Americas. Comments on the draft are currently under review and – after they have been taken into account – the updated version will be sent to all IPEC Federation members for appraisal.

It's worth noting that the current guide – which was published in 2009 - covers the purchase via distributor but does not sufficiently address the relationship between distributor and manufacturer. The new version will cover this scenario with a manufacturer's quality statement.

There was also discussion on the requirements for selecting and qualifying primary packaging materials used for excipients, and a decision taken to draft a position paper on the topic - for review at the next Q&RA committee meeting in September – that will enhance what is covered in the GMP Guide on primary packaging materials.

Other topics on the Q&RA committee radar that were discussed at the meeting included: co-processed excipients;  elemental impurities; the revision of the EXCiPACT standard; drug master files for excipients; atypical actives; quality-by-design and the FDA Critical Path Initiative, specifically its potential as a model for excipient safety evaluations.




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