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MANUFACTURER'S INTERNAL QS AUDIT REPORTS SHOULD BE PUBLIC INFORMATION

This article was originally published in The Gray Sheet

Executive Summary

MANUFACTURER'S INTERNAL QS AUDIT REPORTS SHOULD BE PUBLIC INFORMATION under proposed revisions to FDA's good manufacturing practices regulation, Public Citizen's Health Research Group says in March 25 comments to the agency. Documentation of in-house audits conducted to verify compliance of a firm's quality system should be "available to FDA employees for review and copying, and publicly disclosable," according to HRG.
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