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

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