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• 2023 Annex 1 Manufacture of Sterile Medicinal Products
Part 606 - GMP for Blood and Blood Components
Annex 15 - Qualification and Validation
The GMP 210/211 regulations address issues including recordkeeping
PMA & 510k Guidance Document
21 CFR 11, 58, 210/211, 820, ICH E6(R3) - GMP 2 11 • 2023 Annex 1 ManufactureGMP 2 Combination US FDA Title 21 CFR Parts Part 11 Electronic Records Electronic Signatures (ERES) Part 58 Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Part 210 211 cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals Part 820 Quality Management System Regulations (QMSR) 2026 International Conference on Harmonisation Regulations ICH E6(R3) Good Clinical Practice
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