In-Use Stability

Stability storage and testing

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