1 1

US & EU GMP Regulations with Annex 1 & ICH Q7

US & EU GMP Regulations with Annex 1 & ICH Q7

978-1-935131-55-7

$15.95
$15.95
Sale Sold out
Shipping calculated at checkout.

NEW!  The Sterile Product Update with Annex 1 & ICH Q7

US FDA Title 21 CFR Parts

  • Part 11 - Electronic Records/Electronic Signatures (ERES)
  • Scope & Application 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 GMPs & Annex 1

  • EU GMPs Chapters 1-9 - EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.
  • Annex 1 - 2023 - Sterile Medicinal Products.

International Council for Harmonization (ICH)

  • ICH Q7 GMPs for APIs
View full details
Continue shopping