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Annex 1 – Final Version and its Impact – Current requirements on aseptic manufacturing


This conference offers you a unique possibility to become acquainted with the new regulatory requirements of the revised final Annex 1, the impact on aseptic manufacturing and the challenges relating to quality aspects.


Authority speakers as well as representatives from pharmaceutical industry and experts from technical suppliers will provide you information about their thinking about the new requirements. They will discuss the statements of the new Annex 1 on topics like Quality Risk Management, Process Simulation/Media Fills well as the challenging topics of PUPSIT and the use of Single Use Materials. The widely discussed topic of Contamination Control Strategy will also be discussed and the updated ECA Guide will be presented in support. Subsequently, classical topics of contamination control like environmental monitoring and cleaning and disinfection are considered in the light of Annex 1.



·       Revision Background and Major Changes

·       Future Sterile Manufacturing – Industrial Assessment

·       Expectations on Quality Risk Management (QRM)

·       Qualification of Sterile Facilities & Utilities

·       Process Simulation /Media Fill – Requirements and Challenges

·       Sterile Filtration – Pre-Requisites, must Haves, and Exceptions

·       CCIT

·       From Isolators and Barrier Systems

·       Contamination Control Strategies – Requirement and Approaches

·       Annex 1’s Specific Risks Associated with Single-Use Systems

·       Environmental Monitoring

·       Impact for Cleaning and Disinfection


The long-awaited revised Annex 1 on the manufacture of sterile medicinal products was finally published by the European Commission on August 25, 2022 (1). The main reason for the update was to reflect changes in the regulatory environment and manufacturing, which includes a significant shift towards the application of quality risk management principles. The new Annex 1 will enter into force on August 25, 2023.