EU cGMPs for ATMP with EU GMP Chapters 1-9

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