Annex 1-compliant Contamination Control

When we talk about the Annex 1 requirement for a Contamination Control Strategy, we are talking about an overarching strategy that captures and links the multitude of contamination control measures, considers interactions between them and evaluates any gaps between the individual measures. In addition to this overarching strategy, however, the individual measures should also be implemented according to the state of the art in science and technology, or in compliance with the relevant guidelines, such as Annex 1, the FDA Aseptic Guide or similar, and validated if necessary.

The Contamination Control course of the ECA Academy on 09-11 November 2022  has been dealing with the GMP-compliant implementation of contamination control measures for several years. Several of the speakers, such as Walid El Azab, Robert Schwarz, Axel Schroeder and Arjan Langen were involved in the creation of the ECA Contamination Control Strategy Guideline. In the updated version of the course, 8 speakers offer insight into establishing CC measures and how to integrate them into an overall strategy.