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EU and US GMPs with Q7 API

EU and US GMPs with Q7 API

978-1-935131-02-1

$13.95
$13.95
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US FDA Title 21 CFR Parts:

  • Part 11 - Electronic Records/Electronic Signatures (ERES)
  • Part 11 - Scope & Application August 2003
  • Part 210/211 - GMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
  • Part 820 - Quality Management System Regulations (QMSR) 2026

European Union

  • EU GMPs Chapters 1-9 - EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.

International Conference on Harmonisation Regulations

  • ICH Q7 - Good Manufacturing Practice guide for API
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