FDA's Quality Systems Approach to Pharmaceutical CGMP - What you need to know.

 

5-page question and answer (Q&A) white paper addresses 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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