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.
Stability Testing of Pharmaceuticals Masterclass is a live, two-days course, which begins with an overview of the types of stability study conducted, followed by a review of common chemical degradation reactions. 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 seek-ing global approval for new drug products, the requirements for other regions are described. The science behind photo stability 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. Stability chamber management is an important element of a successful study, and acceptable approaches to excursions are explained.
The quality of test methods used for stability evaluation is also an important consideration, and the course includes a brief introduction to analytical QbD and lifecycle management, and well as data trending and the identification of out-of-trend results. Degradation product growth is often the factor that limits the shelf life of anew drug product, and approaches for justifying impurity levels are explained, including requirements for genotoxic impurities. Finally, since regulators continue to focus on data integrity during regulatory inspections, acceptable approaches to data management, including chromatographic integration, are explained, together with recent examples of regulatory enforcement action relating to stability studies.
An overview of regulatory requirements for stability studies.
A deeper insight into the science behind stability evaluation.
An appreciation of the use of stability evaluation at each stage of drug development.
An understanding of how to design efficient stability studies that meet the requirements of regulatory authorities.
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.