ECA Foundation and European QP Association submit Comments to EU GMP Guide Annex 15 Revision

A concept paper on the revision of Annex 15 was published on the EMA's website in February - with a two-month public consultation period. One of the main objectives of the revision is to make the application of Annex 15 mandatory for active substances (APIs). Until now, its application has been optional for active substance manufacturers. This change will affect both manufacturers of chemically synthesized and biologically derived active substances. In addition, the updates to Quality Risk Management introduced in ICH Q9 (R1) will be incorporated.

Now the ECA Foundation together with its European QP Association submitted comments to the revision.