Memmert: Stability Testing of New Drug Substances and Products Q1A (R2)

This is a guideline developed by ICH Expert Working Group. It promotes health through international harmonisation and defines the stability data package. This package for a new drug is capable for registration application in EC, Japan and the U.S.A.

A stability test shows drug product/substance testing with environmental factor variables - temperature, humidity and light.

It determines the pharmaceutical product's response to any physical, chemical or microbiological changes. It helps establish the integrity and efficiency of the final product and is important for establishing a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

Details on stress testing and storage condition - long term, intermediate, accelerated - are covered and most suitable products for stability testing are introduced.

Webinar key topics:

• ICH Guideline Q1A (R2)
• Stability testing - forced degradation studies - storage testing
• Climate chambers