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European Biopharmaceutical Review

Risk Management for Analytical Method Development

Process development and validation, batch release tests, routine analysis, product characterisation, and stability studies have their foundations in reliable analytical methods. This justifies the existence of a dedicated ICH guideline – the analytical methods validation guideline – ICH Q2 – introduced 25 years ago (1). A significant number of developments have occurred in regulatory science over the past two decades. As such, ICH Q14 will address, in addition to validation (cf. Q2), several new aspects of the analytical procedure’s development that will ensure better performance over lifecycle. ICH Q14 (draft planned for 2020) is expected to expand Q2 and address current regulatory gaps related with explicit use of risk-based considerations and formalised change-management procedures. A similar situation existed for product and process development for which a linkage was established with the development of the ICH Q8, Q9, Q10, and the most recent guideline, Q12, on lifecycle and postapproval change management, LCM and PACM respectively. The concepts of quality by design (QbD), established by Q8, can be extrapolated and adapted for analytical method development – known as analytical quality by design (AQbD). ICH Q14 is expected to integrate the above aspects on risk-based QbD, LCM and PACM.

The current approach to analytical method development does not follow a systematic approach – the work is defined according to the results that are sequentially obtained, which usually leads to non-optimised methods (3). The AQbD process is very similar to the one described in the ICH Q8 (within the pharmaceutical development context), in the sense that it is a structured approach with a predefined goal and a strong focus on method understanding using risk-based and data-driven approaches (4-5). Although it may be necessary to invest more time and effort in the beginning of the development, it is compensated in the long run with less work and shorter timelines. Figure 1 presents the steps involved in the development of an analytical method via the AQbD approach. With this framework, not only is the method’s performance optimised, but the risk-based and data-driven methodologies provide a strong knowledge base to be applied for the lifecycle management. This supports an efficient change-management system and continued method performance and verification activities.



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Madalena R Testas is currently a Senior MSAT Engineer at 4Tune Engineering, responsible for managing and executing projects in both the pharma and biopharma areas. She has worked in several industrial projects with clients in Europe, the US, and South America, involving QbD, quality risk management (QRM), process analytical technologies (PAT), continued process verification, and data science. Madalena holds a BioEngineering degree from the Technical University of Lisbon, Portugal, and a MSc from a top pharmaceutical and equipment supplier in a resource optimisation project using PAT.

Daniela B Santos is the Head of the Business Marketing and Sales department at 4Tune Engineering, responsible for the business development in Europe, the US, and Asia. For almost three years, Daniela was involved in the launch and implementation of the life science department in a multinational consulting company, in a project for a large pharmaceutical company in the area of quality assurance with the execution of extensive technical reports of equipment/systems/processes, aligned with GMP. Daniela holds a master’s degree in Molecular Medicine and a postgraduate degree in Pharmaceutical Management.

José C Menezes, PhD, is President and founder of the international company 4Tune Engineering, with offices in Europe (Lisbon) and Brazil (São Paulo). The company is a world leader in science and technology (MS&T) and risk management (QRM) specialising in the pharmaceutical, pharmacochemical, and biopharmaceutical areas. He has been a Professor at the University of Lisbon, Portugal, since 2005, Director of a Programme in Pharmaceutical Engieering running for over a decade, and one of the world's pioneers in the areas of PAT, QRM, QbD, and and KM for pharma and biopharma operations. Jose has 25 years of experience working with pharma companies in Europe, Brazil, and the US.
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Madalena R Testas
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Daniela B Santos
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José C Menezes
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