Collection of US GMP’s applicable to Combination Products:
21 CFR Part 4 Regulation of Combination Products
21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 820 Quality System Regulation (Medical Devices)
21 CFR Part 11 Electronic Records; Electronic Signatures
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