Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach
5-page question and answer (Q&A) white paper addresses FDA's initiatives for 21st Century CGMPs and the modernization of pharmaceutical quality systems. While the FDA encourages modernization and harmonizing with other quality system requirements, the agency is also required to ensure manufacturers comply with CGMPs (21 CFR Parts 210, 211) and electronic system requirements (21 CFR Part 11).
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