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FDA bulk actives GMP guidance returned to draft form by ICH's foray into GMPs.

This article was originally published in The Tan Sheet

Executive Summary

FDA BULK ACTIVES GMP GUIDANCE RETURNED TO DRAFT form as a result of the International Conference on Harmonization's decision to begin work immediately on its own guidance on the subject. The agency's guidance on active pharmaceutical ingredient Good Manufacturing Practices, which has been in development since 1993, was "in final form and ready to be published," FDA Office of Compliance Director Stephanie Gray said at the recent University of Texas-sponsored International Industrial Pharmacy Conference in Austin, Tex.
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