Thursday, 29 September 2022 9 .00 - 15.30 h
Industry is still waiting for the new Annex 1 of the EU GMP Guideline - and there is still speculation about the implementation time after publication. The latest information available is that a final version is probably with the responsible bodies of the European Commission for signature.
But that does not stop industry from preparing for publication. You could already read about the new requirement for a strategy for contamination control measures defined in the revised Annex 1. To provide assistance in preparing and documenting such a strategy, the specifically set up ECA Contamination Control Strategy Expert Task Force developed
and made it all available to all interested parties free of charge.
Based on the information currently available on Annex 1 and on some suggestions and comments received after the publication of the first version of the Contamination Control Strategy Guide, Attachment 3 of this guidance document has now been revised to make it clearer and easier to understand in some places.
Attachment 3 comprises the "Template for the Contamination Control Strategy Document (example)". The following points have been changed:
If further versions of Annex 1 or the final document are published, updates will of course follow.
Further information and the download of the guide can also be found on the ECA Foundation website.