The new ICH Q14 guideline "Analytical Procedure Development" describes principles for the approach to analytical procedure development and life cycle concepts for analytical test methods. Together with the revised Q2(R2) "Analytical Validation", the requirements for analytical development and procedure validation have been fundamentally revised.
In our intensive seminar at the Ammersee, we will present the changes and additional requirements for analytical validation resulting from the revision of ICH Q2 in a structured manner. With the introduction of a life cycle concept for analytical test methods with ICH Q14, there are also numerous aspects that must be taken into account in the context of pharmaceutical quality control in the future. This will apply from region-specific implementations at the latest (in the EU already on 14 June 2024). We will present conceptual approaches on how the existing requirements can be implemented in practice. Finally, there are a number of other current developments that are relevant in the context of the validation of analytical test methods, such as the harmonisation of Chapter 2.2.46 on chromatographic separation methods in the European Pharmacopoeia and the new Chapters 5.26 on the verification of pharmacopoeial methods and 5.27 on requirements for alternative test methods. The revision of the USP chapter <1058> on the qualification of analytical devices with newly introduced life cycle concepts should also be mentioned here.
We have prepared and structured the contents of all these topics for you, so that you can use our seminar to obtain targeted and focussed information and familiarise yourself with the current requirements.