Recently, the long anticipated ICH M10 Bioanalytical Method Validation and Study Sample Analysis arrived, facilitating countries to be able to use the same guidelines upon adoption by their respective regulatory agencies. It is wonderful to have the ICH M10 because it harmonizes across countries that have adopted it and there will be many, many more that are going to, even if they aren’t quite there yet.
Unfortunately, when we look across the current landscape of these guidelines, we do not see anything that actually compares these standards and what they mean from the vantage point of a CRO – those who are doing the bioanalytical analysis. We see a few comparisons in the beginning, but we do not see anything that really defines what the impact is to a bioanalytical CRO. I collaborated with two of my other KCAS colleagues to put together this internal whitepaper as a reference for others – whether they are CROs or other bioanalytical labs – who want to make sure they have captured some of those differences and accounted for them. There could be implications if they were not captured after these guidances and guidelines were adopted. In order to ensure compliance with that guideline and guidance, we wanted to share this, so they could have all of the changes in place.
For LBA, there were not many changes, but for Mass Spectrometry there were. These updates were more aligned with the past EMA guidelines. Making sure that a CRO has those things in place is very important. It will also be important for our clients to understand what to expect going forward. There are going to be some differences, especially with Mass Spec, that may have other implications for scope of work and other related elements. Understanding this is important, as well as giving consideration for validations that were completed prior to this new guideline and guidance coming into effect. It will be important to consider what things will need to be changed or updated and how KCAS is going to look at those.
As I am overseeing quality and regulatory compliance, I helped to coordinate our teams so we could have this internal whitepaper offered for other CROs to review, and for our clients to examine, also. Additionally, ICH M10 deals with Mass Spec and LBA both of which are used heavily at KCAS by our clients, so it was important that the leaders from those teams be included in this internal whitepaper.
The benefit of this internal whitepaper is that other laboratories who are looking to make sure they have captured all the differences will have one place to go as a reference. In this internal whitepaper, we went into more detail. We hope anyone who is setting up either for the first time in the laboratory against this new guideline or transitioning into this guideline will find it helpful.