Join Dr. Mark Powell as he discusses Temperature Excursion and Cycling Studies.
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.
This webinar will cover:
• 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
This webinar is hosted by Q1 Scientific, a global leader in environmentally controlled stability storage and sample management.