Annex 1 - Final Version and its Impact - Live Online Conference

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.

The Annex 1 “Manufacture of Sterile Medicinal Products” was published for the first time in 1971. During the following years it was updated several times, as example to align classification table of clean rooms, to include guidance on media simulations and bioburden monitoring in 2005 and 2007 or relating to capping of vials in 2010.

At the end of 2017, the first draft of a fundamental revision was published, which was intended to focus on more structured guidance, including state-of-the-art principles such as quality risk management and the consideration of new technologies and innovative processes. The draft now contained new sections, e.g. for utilities, and extended sections on topics such as production and specific technologies or on the requirements of Aseptic Process Simulation (APS).

During the subsequent public consultation, over 6000 comments were submitted to EMA, which were then processed alongside the challenge of moving to Amsterdam. This resulted in the current document, which was published on 20 February 2020 for a second, restricted consultation. After reviewing the approximately 2,000 comments submitted, the Inspector Working Group (IWG) finalised the report at the beginning of 2022 and forwarded it to the responsible bodies of the European Commission for final approval.

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.