Overview of Stability Programs and Storage Statements
- Stability studies and development phases
- Long-term and accelerated storage conditions of new drug substances and products (EU, USA)
- Stability storage programs for generic drugs (EU, USA)
- Specific storage statements (EU, WHO, USP)
- Labeling statements for various pharmaceuticals
Mean Kinetic Temperature (MKT) and World Climatic Zones
- Mean Kinetic Temperature (MKT) and relative humidity
- Interpretation of MKT
- MKT from temperature loggers
Q&A Session I
Stress Studies of Pharmaceuticals
- Degradation reactions
- Stressing factors and conditions
- Stress studies in the pharmaceutical industry
Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals
- Stress testing vs Forced Degradations
- Studies at elevated extreme temperatures
- Studies at low extreme conditions
- When, how and what?
- Thermal Cyclic studies
- What attributes to test
Q&A Session II
Investigation of Excursions from Storage Label Conditions
- “Time-out-of-Storage” and stability budget“ concept
- Handling an excursion
- What stability data are required to investigate temperature excursions
- Responsibilities of manufacturer, distributor and QP
Evaluation of the Impact of Temperature Excursions
- Estimation of the impact by the excursion temperature on the quality attribute
- Estimation of the quality attribute at the end of shelflife/retest date
Q&A Session III
Three Q&A sessions ensure interaction and that your questions are answered.