21 CFR 11, 58, 210/211, 820, ICH E6(R3) - GMP 2

GMP 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 Systems Regulations

International Conference on Harmonisation Regulations

ICH E6(R3) - Good Clinical Practice

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GMP2-11-58-210210-820-E6-C-251218