Risk Assessment in Contamination Control

Risk-based approaches have gained considerably in importance in all branches in recent years. Pharmaceutical production, quality assurance and quality control would be unthinkable without them. Starting with the FDA initiative “cGMPs for the 21st Century” for the introduction of the risk-based approach, through the subsequent ICHQ9 guideline on risk management, which can now be found as Part III of the EU GMP guidelines, to the revised Annex 15 with a wealth of risk analyses, these principles are anchored everywhere. With the revision of Annex 1, risk management is also increasingly becoming part of the main guideline for the manufacture of sterile pharmaceutical products.

In this workshop on the principles, regulations and application of risk assessment in the context of contamination control, you will gain insight into the relevant underlying guidelines and guides as well as valuable pointers for practical implementation using practical examples. The following areas are covered: