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FDA updates GMPs

This article was originally published in The Tan Sheet

Executive Summary

FDA revises its good manufacturing practice regulations for finished pharmaceuticals to clarify some of the requirements and harmonize them with other FDA standards and international GMPs as part of its first phase of its incremental approach to modifying the GMPs for finished drugs, according to a final rule published in the Sept. 8 Federal Register. Specifically, the rule revises requirements related to aseptic processing, verification of performance of operations by a second individual and use of asbestos filters. The rule applies to all finished pharmaceuticals, both under new drug applications and OTC monographs. "We are pleased to see the agency updating GMPs and feel it is important they continue to do so," commented Elizabeth Funderburk, Consumer Products Healthcare Association director of communications

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