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.
Click the titles below for complete guidelines
Table of Contents
8.
Seed lot and cell bank system
10.
Qualification and validation
11.
Qualified person and batch release
14.
Quality defects and product recalls
15.
Environmental control measures for ATMPs containing or consisting of GMOs
16.
Reconstitution of product after batch release
EMA Guidelines on GMP Specific to ATMP
