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FDA basic regulations

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21 CFR part 58:
Quality system approach (GLP) for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.
21 CFR part 210:
Outlines the minimum GMP requirements covering manufacturing, facilities, and controls for the manufacture, processing, packing, and holding of all drugs in a way that meets the guidelines for safety, quality, and purity.
21 CFR part 211:
The cGMP regulations for validating pharmaceutical(drug) manufacturing require that drug products be produced with a high degree of assurance of meeting all the attributes they are intended to posses
Part 211 also covers various other areas, including personnel, facilities and equipment, production processes, stability testing, and labeling.
21 CFR Part 820 quality system regulations exist to make plain the Current Good Manufacturing Practice (CGMP) guidelines that pertain to the quality processes employed during the design, manufacturing, packaging, labeling, storing, installing and servicing of finished medical products.
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