21 CFR 11, 210/211, 820, ICH Q7 - GMP Std Handbook

21 CFR 11, 210/211, 820 QMSR, ICH Q7 - GMP Std Handbook:

US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures and includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.

US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices - The regulations set forth in parts 210/211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug product.

US FDA Title 21 CFR Part 820 - Quality Management System Regulations (QMSR) 2026 The methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

ICH Q7 - International Council of Harmonization (ICH) Q7 Good Manufacturing 
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.  It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

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