As early as 2018, the ICH announced that the Q2(R2)/Q14 Expert Working Group (EWG) would develop a new ICH quality guideline, ICH Q14, for the development of analytical methods and revise the ICH Q2(R1) guideline for the validation of analytical procedures. This will complement the existing ICH Q8 to Q12 guidance and the current ICH Q13 guidance for continuous manufacturing. The new Analytical Procedure Development Guideline (Q14) will then be relevant for sections S4, P4 and P5 of the CTD and should be seen together with Q8(R2) and Q11 as a supplement to the guidelines. The use of the enhanced approach to analytical procedures development and validation can contribute to resource-efficient drug development as well as submission process or facilitate changes after CMC approval. The revised Q2(R1) guideline will also be relevant for sections S4, P4 and P5 of the CTD, with an emphasis on systematic analytical development. As development and validation are linked and subsequent steps, both guidelines will be worked on by the same Expert Working Group, with a potential to combine both documents into one.
The purpose of the 2-day course, Analytical Method Validation & Lifecycle Management Masterclass, is to explain these new guidance in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development, validation, verification, transfer and post-approval change of test methods, whether for biological or chemical drugs. Key concepts such as the Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) will be explained with examples. Test methods often lack robustness because of poor documentation, which can lead to errors or high variability during routine use or method transfer. A risk-based approach to method documentation is included in the course.
Each day will conclude with a workshop that will give participants the opportunity to put into practice what they have learned.
Key Topics
Learn how to write an effective ATP
Learn how to set meaningful system suitability criteria as part of the overall ACS
Dive deep into writing method validation, verification and transfer protocols and setting appropriate acceptance criteria
Understand allowable changes to compendial chromatographic methods
Understand how you can avoid common errors in test method documentation and follow a risk-based approach
Learn how to deal with method validation failure
Design suitable method validation, verification and transfer experiments
Get yourself updated on current regulatory expectations including FDA guidance
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Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s AnalyticalDivision and led a working group on continuing professional development until July 2016.
He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes, including stability evaluation.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved managing the analytical and stability aspects of early and late-stage pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, root cause analysis and stability/stress studies.
