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

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 - (2023) 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