Learnings from the new Annex 1

With the new Annex 1, we can expect much more detailed requirements for sterile manufacturing. We will show you what you need to focus on anew and how to properly set up your contamination control strategy within the framework of the pharmaceutical quality system using quality risk management. This will be demonstrated with an example.

Furthermore, we will explain what the biggest influencing factors are for new fill-finish plants. What are the impacts of Annex 1 on cleanroom qualification? And what changes occur in cleanroom clothing, especially in gowning? Additionally, we will outline what insights have been gained from implementing the requirements of Annex 1, such as the Swiss Medic interpretation of EU GMP Annex 1 and much more.