There has been a significant change to the guidance for validations and requalification in Annex 1. Previously, validation was recommended to be completed to ISO 14644-1. Now, Annex 1 details the testing that is expected in the initial qualification, then what is needed as part of the requalification.
C2C is already implementing EU GMP Annex 1. So, when the draft becomes live, our clients will already be compliant.
Are you ready for EU GMP Annex 1?