The current version of EU-GMP Annex 1 deals particularly intensively with the topic of risk assessment. This is a strict prerequisite for a monitoring plan and also makes sense for practical reasons. A thorough understanding of the process makes it possible to optimally design and monitor production processes and avoid additional effort in routine monitoring.
Critical process steps and relevant sampling points are defined in the risk assessment. This requires a detailed understanding of the manufacturing process in order to assess the overall risk of product contamination using appropriate quality risk management tools. Finally, monitoring frequencies and methods are developed based on several considerations, with corresponding justifications.
In addition, warning and action limits must be set based on prevailing guidelines and historical analysis of the collected monitoring data. In our presentation, we would like to explain why risk assessment is so important and what the EU-GMP Annex 1 requires. We will also walk through the risk assessment process using case studies and explain the applicable methods.