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What the people want from ICH Q3E?

For those who are unaware, an expert working group is currently considering what to include within a new quality guidance document for E&L (extractables and leachables). It will have the designation ICH Q3E and will join a number of other guidance documents written by ICH for pharmaceutical impurities.


I recently gave a presentation on my personal hopes for what will be included in this document and you can see that presentation here. I hope people will find that of some value but I wanted to share today three of the Poll questions I included in that presentation and the results obtained.


I must say I am a sucker for a Poll / vote. You never quite sure what you are going to get from it and invariably some very interesting aspects to the result. So before I get diverted into a side conversations around surprise referendum / election results of the last few years I like to share the first of the three questions I posed.


Question 1: Which of the following areas is most important for ICH Q3E to provide clarity on?




As you can see the results of this question were quite distinct and not perhaps surprising, with 50% of the voters asking for a focus on a clarity around safety thresholds.


What is more interesting are the order of the remaining choices. There seems a real desire to clarify experimental requirements ahead of definitions of terms. It would be great to discuss why this might be so. I understand the desire for, “just tell me what I need to do” but this area is one that is hard to reduce to a standard method or standard solvent choice so I think ICH Q3E might struggle to give the people what they want there.


My second question was


Which of these common terms E&L terms would benefit the most from consensus in definition by ICH Q3E?



Once again there was a clear favourite, “Analytical Uncertainty Factor” and again its not difficult to see why this might be most popular. Again voters want to see the removal of doubt in approach. However, once again they may be disappointed that the concept of analytical uncertainty is not fully resolved in the guidance. Perhaps though we can move that forward and clarify at least how and when it is appropriate?. I must admit I am surprised the term “exhaustive extraction” received no votes! and target leachable was also low. Both these terms are in common use but in particular exhaustive extraction would benefit perhaps not from a clearer definition but certainly a better understanding of when it might be appropriate to use.


My third and final question included the word control.


Which of these topics needs the controls defined with ICH Q3E?




Here we again see a link to safety of leachables and this is indeed one of the most important reasons for conducting leachable studies. But I think you can see in these results that the topic of E&L does have all the other elements included here to consider which continues to make this area so engaging and interesting to work within.


I do hope the future ICH document can live up to the expectations which are perhaps in line with these Poll results. It is clear that the document will have to satisfy a diverse set of requirements. I hope the expert working group is able to rise to the challenge and also has time to reflect on results such as Polls which can sometimes give insight into the priorities voters have. 2023 will see the start of public consultation on the proposals so opportunity beckons for a review of the document and commenting.


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