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US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures with Scope and Application 2003 - FDA Interpretation of Part 11.
US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices - The regulations containing the minimum CGMPs for methods, facilities or controls to be used for manufacture, processing, packing, or holding of a drug product.
US FDA Title 21 CFR Part 820 Quality Systems Regulation The controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices.
ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. The ICH Guidance supporting APIs for manufacturing of Drug Substance for Finished Products.
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