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.

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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.   

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

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To access the guideline, follow this website: https://owlpharma-25787080.hubspotpagebuilder.eu/annex1

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Contact us at owlpharma@owlpharma.pt for further information and queries!