Manufacturing of ATMP starting materials – is GMP required?

On 23 Apr 2021, EMA published an important addition to their GMDP Q&A with the publication of ‘Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs’.

The document highlights that, whilst GMP certificates are not required for manufacturing and testing sites of starting materials for ATMPs, it is mandatory to comply with the ‘principles of GMP’.

The first Q&A covers the definition of starting materials.

Q&As 2-5 then go on to explain further what is meant by ‘principles of GMP’ for different types of ATMP manufacture. The application of a risk-based approach is expected to determine the risks presented by each material to quality, safety and function, thus determining the appropriate GMP controls and other mitigation measures.

The final two Q&As reinforce that this is an obligation of the ATMP manufacturer and confirm that a qualified person is not required for the production of starting materials.

For more details: access the GMDP Q&A entry portal or directly the document