Stability evaluation occurs at various stages during the development of a drug product. At early development stages, it is used to select formulations and packaging configurations that are most likely to give a commercially viable shelf life. At later stages, stability data from formal studies is used to justify product shelf life (in the primary pack), shipping excursions and process hold times. This course covers the science behind stability evaluation as well as regulatory expectations.
Risk-Based Stability Evaluation of Pharmaceuticals Masterclass is a live, two-days course, which begins with an overview of the types of stability study conducted (including predictive stability studies), followed by a review of current regulatory expectations. It is important that forced degradation studies are predictive of real-time and accelerated conditions, and an approach that makes this more likely is described, including the use of a humidity-corrected Arrhenius model (Accelerated Stability Assessment Programme, or ASAP).
Within the ICH regions (Climatic Zones I and II), the Q1 stability guidelines are followed, but for companies seeking global approval for new drug products, the requirements for other regions are described. The science behind photostability evaluation is explained, together with the requirements for data trending and reduced study designs (bracketing and matrixing). The stability of biological products (ICH Q5C) is described, together with typical protein degradation pathways and analytical approaches.
Recently, the IQ Consortium has published a series of papers proposing updates to current stability guidance. They have recommended a risk-based life cycle management approach to stability evaluation for chemical drugs and biologics in line with the principles of Quality by Design (ICH Q8), quality risk management (ICH Q9) and drug product life cycle management (ICH Q12). The IQ Consortium approach focuses on understanding the risks to drug product stability and designing a formulation (including material attributes), manufacturing process and primary pack that together mitigate those risks.
You want to understand how to design effective and efficient stability studies
You would like to know more about the science behind stability evaluation
You would like to understand how to design stability studies in line with the principles of Quality by Design
You want to understand the key inputs to stability prediction tools
You want an overview of regulatory requirements relating to stability studies
You would like to get a deeper insight into risk-based stability evaluation
You would like to improve the predictive nature of stress studies
You would like to improve data quality and your approach to result trending
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.
