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EU Considers Including High-Profile Excipients in Applying GMP to API

This article was originally published in The Gold Sheet

Executive Summary

Political pressure in the EU puts two in-the-news excipients on EU GMP list.

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Deeper understanding of the role of excipients in drug formulations is leading manufacturers and pharmacopoeias to develop new more science-based approaches and standards for them. Variability of excipients should be expected: the key is to know which variables are important - and how to counterbalance them. The flexibility of QbD could play a key role. Compendial tests often do not focus on the critical attributes. USP and EP are working to upgrade their excipient standards. USP <1059> draft is seen as step in the right direction with its offering of functional guidance in a general information chapter. Industry fears the 'non-mandatory' functionality-related tests the EP wants to add to excipient monographs would eventually become mandatory. FDA and IPEC work to unfetter novel excipients. FDA would create an excipient functionality database. Regulatory requirements for excipients could be helpful, but progress is slow. Third-party certification could suffice in the interim, though uptake remains slow.

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