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FDA first-party audit program voluntary participation needs added incentives -- industry.

This article was originally published in The Tan Sheet

Executive Summary

FIRST-PARTY AUDIT PROGRAM FOR SELF-REPORTED GMP COMPLIANCE requires greater incentives to encourage voluntary participation, drug industry representatives told FDA at an "industry exchange" meeting in Washington, D.C. June 23. FDA announced the Good Manufacturing Practices modified inspection pilot program April 14 ("The Tan Sheet" April 20, p. 24). The program would enable firms with solid quality assurance processes to be subject to less extensive agency inspections.
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