Stability testing demonstrates how the quality of a drug substance or drug product may be influenced by temperature, light, humidity and other environmental factors, and is used to establish shelf life and recommended storage conditions. Studies to evaluate any physical, chemical, biological, and microbiological attributes that may change during storage can be complex and costly.
In this educational webcast, participants will learn about regulatory expectations and practical approaches to stability testing of both small- and large-molecule drug substances and drug products for packaging, storage and transportation.
Experts will review global regulatory requirements and guidance documents for drug stability testing, discuss a risk-based approach to testing for different stages of the product life cycle, and explore in detail special considerations for evaluating the impact temperature excursions, vibration and other environmental factors may have on the drug product during shipping.
Founder and President
Coastal Pharmaceutical Consulting
Senior Director, Global CMC
Pfizer Global R&D
Operational Laboratory Manager
SGS Life Science Services
t: 973 276 8463