GMP Publications - Code of Federal Regulation Handbooks by the FDA

EU cGMPs for ATMP with EU GMP Chapters 1-9 and Annexes 1, 8, 11, 13, 14, 15, 16 & 19

ATMP1

EudraLex
The Rules Governing Medicinal Products
in the European Union
Volume 4
Good Manufacturing Practice

Guidelines on Good Manufacturing Practice
specific to Advanced Therapy Medicinal Products


Adoption 22 November 2017
In Operation: 22 May 2018

Advanced therapy medicinal products that are administered to patients under Article 3(7) of Directive 2001/83/EC1 (so called “hospital exemption”) must be manufactured under equivalent quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorisation.

This guide is used to assist with the GMP Implementation of ATMPs. Supersedes Annex 2.

Includes EU GMPs Chapters 1 - 9:

  • Chapter 1 - Pharmaceutical Quality System
  • Chapter 2 - Personnel
  • Chapter 3 - Premise and Equipment
  • Chapter 4 - Documentation
  • Chapter 5 - Production
  • Chapter 6 - Quality Control
  • Chapter 7 - Outsourced Activities
  • Chapter 8 - Complaints and Product Recall
  • Chapter 9 - Self Inspection

Annex:

  • Annex 1 - Manufacture of Sterile Medicinal Products
  • Annex 8 - Sampling of Starting and Packaging Materials
  • Annex 11 - Computerised Systems
  • Annex 13 - Manufacture of Investigational Medicinal Products
  • Annex 14 - Manufacture of Products derived from Human Blood or Human Plasma
  • Annex 15 - Qualification and validation
  • Annex 16 - Certification by a Qualified Person and Batch Release
  • Annex 19 - Reference and Retention Samples
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