How did the EMA Q&A Document on the use of PDE Values come about?

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

In June you could already read about the final Q&A Document of the European Medicines Agency (EMA) on the use of PDE (HBEL) Values in connection with cross contaminations and cleaning validation.

This document finalised a draft from 2016. The draft version had become necessary in 2016: indeed, the EMA had generated uncertainty among the pharmaceutical industry with their Guideline on setting these limits (PDE values as well). The Permitted Daily Exposure (PDE) values had been defined by the EMA in a new guideline in order to mathematically decide upon the dedicated or multi-purpose use of plants. The new health-based values influence the cleaning validation threshold values as well. In brief, it can be determined how much cross contamination may be tolerated from a health risk point of view by using the PDE values. For identifying and using these values, the EMA had to provide a Q&A document.

In 2017, this draft document was open for public comments and a workshop on that topic took place with toxicological and quality experts. Now, the workshop results have been published in a report presenting how the contents of the finale version of the 2018 Q&A document were achieved.

So in case you are looking for some background information on why and how the differences between the two documents came about, you might read the report. It contains in total five pages which is a manageable reading. What is noteworthy is that many consultants participated in the workshop which eventually led to the final document.

On the EMA website you can find the "Summary report of comments received during the public consultation and next steps".