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NDMA objects to proposed requirement that "all" production processes be validated.

This article was originally published in The Tan Sheet

Executive Summary

VALIDATION OF "ALL" MANUFACTURING PROCESSES QUESTIONED BY NDMA in comments on FDA's May 3 proposed rule, which is aimed at updating the good manufacturing practices regs. Submitted to FDA on Oct. 8, the comments from the Nonprescription Drug Manufacturers Association suggest that process validation, while "a useful tool" to assure product consistency, "is only useful when applied to those parts of a process that have an effect on these quality attributes."
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