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Threat of Sanctions, Shortages, Spurs Talk of Standards for Atypical Actives

This article was originally published in The Gold Sheet

Executive Summary

As the pharmaceutical supply chain comes under increased regulatory scrutiny, FDA inspectors are finding manufacturers using excipients as active ingredients, even though they don’t meet active ingredient standards, and the industry is talking about establishing a new set of standards for these so-called atypical actives, and perhaps coaxing FDA into ratifying them via guidance.

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Regulatory Updates in Brief

ICH association convenes; ISO revises cleanroom standards; NSF accredited for excipient GMP certification; supply chain library launched.

Europe Allows Derogation of Atypical Actives from ICH Q7

The European Medicines Agency tackled the issue of atypical actives in 2008, David Cockburn, head of manufacturing quality compliance at EMA, told a recent PDA workshop in Bethesda, Md.

Europe Allows Derogation of Atypical Actives from ICH Q7

The European Medicines Agency tackled the issue of atypical actives in 2008, David Cockburn, head of manufacturing quality compliance at EMA, told a recent PDA workshop in Bethesda, Md.

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