New in Annex 1: The Contamination Control Strategy (CCS) – What does it mean? What does it mean for me as a user?

– Annex 1
– Contamination Control Strategy
– Quality Risk Management
– Aseptic
– Sterile

The kickoff event for the online seminar series on the topic of Annex 1 recently took place. With around 100 participants, it was met with great interest. The goal of the first online seminar was to provide an insight into the current activities and the various aspects and topics of the ongoing Annex 1 revision. During the seminar, participants selected topics related to the Annex 1 revision through polls, which will be discussed in more detail in subsequent online seminars of the series. Based on this, members of the CoP Aseptic are preparing further online seminars to be held throughout the year and beyond. The next event will take place on October 29, 2020, on the topic "New in Annex 1: The Contamination Control Strategy (CCS) – What does it mean? What does it mean for me as a user?".

In the meantime, the re-commenting of the Annex 1 draft by the invited industry associations (Targeted Review) has taken place. These several hundred comments are currently being evaluated and possibly incorporated by the IWG (International Working Group Annex 1). The implementation of Annex 1 is now expected for the first half of 2021.

Annex 1 fundamentally builds on the development of a so-called Contamination Control Strategy (CCS) as the basis for every sterile manufacturing process, both terminally sterilized and aseptic. By consistently applying risk management principles, such a CCS should be integrated into quality management. This event will discuss what lies behind such a CCS, what the expectations for such a strategy are, and what can be achieved through the introduction of this CCS. Users will also consider how such a CCS should look, what elements it should contain, and how this CCS can be represented and practiced within the quality management system. What will be expected during inspections?

For the concrete implementation and thus the successful and safe manufacture of sterile medicinal products, the correct application of risk management is of crucial importance. When can/should decisions be made based on risk? When must strict guidelines be followed? Since Annex 1 will not define formal requirements, this event will also discuss possibilities for practical implementation for on-site users.

The Contamination Control Strategy and the Quality Risk Management are applicable to all other technical topics of Annex 1. The online seminar series will therefore continue with events on barrier systems, cleanroom qualification, aseptic process simulations, and filtration techniques. Details and dates will follow.