Overhauling Compliance and GMPs

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Pharmaceutical Technology, Pharmaceutical Technology-04-02-2003, Volume 27, Issue 4

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.

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Regulatory/GMP ComplianceQuality SystemsRegulatory WatchPharmaceutical Technology-04-02-2003