Temperature Excursion and Cycling Studies

Stability storage and testing

Temperature excursions during shipment can cause the recall of drug product lots, leading to delays in supply and loss of revenue.  Data from a well-conducted temperature excursion and/or cycling study can be used to justify such excursions.  There is currently no harmonised guidance dealing with the impact of temperature excursions during distribution or the effect of freeze/thaw cycles on liquids and semi-solids.  This webinar reviews best practice in these areas.

Topics covered include:

  • Overview of regulatory guidance
  • Temperature excursion risks to physical and chemical product stability
  • Evaluating possible excursions using supply chain knowledge
  • Temperature excursion studies
  • Thermal cycling studies
  • Transportation control strategy