Andreia Ferreira
August 29, 2022

Annex 1 - Manufacture of Sterile Medicinal Products

Later last week, the new Annex 1 “Manufacture of Sterile Medicinal Products” has been published and our team has scrutinized the new guidance and their main changes.

As always, count with us for the implementation of this new document, namely through:

     •    Preparation and implementation of the Contamination Control Strategy; 

     •    Training on the new annex and the main changes; 

     •    Gap assessment between your company practice and the new annex requirements.   

Don´t forget that new requirements are to be implemented until 25/08/2023!

To access the guideline, follow this website:

Contact us at for further information and queries!

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