Dealing with regulatory expectations on product residue limits

Many cleaning validation professionals find it challenging to deal with regulatory expectations on product residue limits. Global regulatory expectations on this topic differ and many manufacturers with EU and global markets are struggling with the lack of clarity and hybrid approaches.

In guidance, the EMA made it mandatory to establish Health-Based Exposure Limits (HBEL) for all the drug products based on Permitted Daily Exposure (PDE) Values as described in Appendix 3 of ICH Q3C (R4). The guideline was soon followed by a Q&A on the implementation of the above guideline. The full Q&A is a must-read, however, recently we find regulators pushing some key items as mandatory. This could impact your QMS and even your business.

You will learn about

Our full-day Masterclass will provide you with a deep-dive in Cleaning Validation. In the morning session, you will learn our best in class practices on Regulatory Compliance, Policy, PQ strategies and Life Cycle Management. In the afternoon we dive into product residue acceptance limits calculations, using the conventional (therapeutic based) and PDE based approaches. With hands-on and practical sessions you will learn all the essential insights. In cooperation with subject matter expert Anja Slikkerveer, an independent toxicologist at d2team, we will explain the interpretations and determination of PDE values.

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