The intent of Annex 1 is to provide guidelines for the manufacturing of sterile products but not only! The new Annex 1 suggests that certain principles and guidance can be used to support the manufacture of other products that are not necessarily sterile, such as certain liquids, creams, ointments and biological intermediates.

The interpretation and implementation of this new Annex 1 will be discussed with our experts in contamination control strategy, drug substance and drug product manufacturing, microbiological and particles monitoring and aseptic process simulation at the next A3P forum to be held at l’Aquatis in Lausanne on March 16. 2023.

Official language of the conference: English

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