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In-use stability

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The requirements for in-use stability for multi-dose medicinal products are not well described in harmonised regulatory guidance. This webinar explains the current regulatory landscape, the quality considerations for in-use studies and practical tips on scientifically sound study designs.

Topics covered include:

  • In-use stability testing in context
  • EMA guidance on in-use stability testing
  • Expectations of other regulatory bodies
  • Physical, chemical and microbiological risks for multi-dose products
  • Requirements for solid oral dosage forms
  • Study design

Guest speaker

Dr. Mark Powell, Director at MP Scientific

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 Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of 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 as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.

He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.