GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

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US FDA Title 21 CFR PARTS 11, 210/211 and 820 Pocket Guide

3 popular regulations in an easy to carry pocket handbook.

  • US FDA Title 21 CFR Part 11
  • Part 11 Electronic Records; Electronic Signatures
  • Scope and Application - August 2003

This regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records. This part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.

Also 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 to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
  • US FDA Title 21 CFR Part 820 Quality Systems Regulation The requirements in this part govern 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.

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