Excipient stability regulations are different than that of drug product and API, but have similar expectations. While many excipient products are stable and may not require extensive testing to assure stability, the stability of excipients is an important factor contributing to the overall quality of the drug product. This webinar has been designed provide an overview for why excipient stability data is needed and discuss when special stability studies/data may be necessary and/or desired.
Learning/Awareness Objectives
Attendees were provided with an understanding for:
> why excipient stability data is necessary
> what stability testing should include
> definition for common stability terms
> overview of IPEC Excipient Stability Program Guide (2010)
> overview of IPEC position paper on excipient stability
> current thoughts on climate zone stability studies, expanding retest intervals and temperature cycling/shipping studies
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs