21 CFR 11, 58, 210/211, 820 - Master GMP Trainer 820 and the facilities and controls

and the facilities and controls used for

The GMP 210/211 regulations address issues including recordkeeping

Practice Guidance for Active Pharmaceutical Ingredients - The Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality

• EU EudraLex - Volume 4 - Good Manufacturing Practice (GMP)

21 CFR 11, 58, 210/211, 820 - Master GMP Trainer 820 and the facilities and controlsMaster GMP Trainer US FDA Title 21 CFR Parts: Part 11 Electronic Records Electronic Signatures (ERES) with Scope and Application 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 Pharmaceutical GMPs for the 21st Century A Risk Based Approach (2004) Quality Systems