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FDA Releases Draft Guidance for Ensuring Drug Product Quality
January 05, 2025
WASHINGTON, Jan. 5 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance document titled "Considerations for Complying With 21 CFR 211.110." This guidance is intended to help manufacturers comply with regulations regarding ensuring batch uniformity and drug product integrity. It also addresses the use of advanced manufacturing techniques and process models in drug production.

The current Good Manufacturing Practice (CGMP) regulations require manuf . . .

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