The current EU GMP Annex 1 version deals particularly intensively with the topic of risk analysis. This is a strict basic requirement for a monitoring plan and it is also useful for practical reasons. This process understanding exercise enables customers to optimally design and monitor their processes to avoid additional effort in routine scenarios.
In the risk analysis, critical process steps and their relevant sampling points are defined for each analysed area. This requires a detailed knowledge and understanding of the manufacturing process to assess the overall risk of contamination of the product via appropriate quality risk management tools. Finally, based on several considerations, monitoring frequencies and methodologies are also proposed with suitable justifications. In addition, based on our accumulated knowledge of guidelines and historical analysis of collected monitoring sampled data, warning and action limits must be determined. In our presentation, we would like to explain to our customers why risk analysis is so important and what is required by EU GMP Annex 1. We will also go through the process of a risk analysis using case studies and explaining the applicable methodologies.