EMA Guidelines on GMP Specific to ATMP

EMA Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products

These Guidelines are specific to ATMPs. Other documents developing GMP requirements for medicinal products which are contained in Volume 4 are not applicable to ATMPs, unless specific reference thereto is made in these Guidelines.

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Table of Contents

1.   Introduction

2.   Risk-based approach

3.   Personnel

4.   Premises

5.   Equipment

6.   Documentation

7.   Starting and raw materials

8.   Seed lot and cell bank system

9.   Production

10. Qualification and validation

11. Qualified person and batch release

12. Quality control

13. Outsourced activities

14. Quality defects and product recalls

15. Environmental control measures for ATMPs containing or consisting of GMOs

16. Reconstitution of product after batch release

17. Automated production of ATMPs

18. Glossary

EMA Guidelines on GMP Specific to ATMP