ICH Stability Testing and Method Development

Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. This presentation will provide a brief overview of the ICH guidelines for Stability testing, as well as aspects of analytical method development.

[@AngieSim-vn8vz]

Excellent presentation. Thank you

[@angelchihoo2669]

Need Q1D, Q1E and Q1F for my college studies assignment but this is very informative

[@adrielismael1904]

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[@bencybabyt]

very informative....

[@venicelow6177]

Hope u still accept questions here: 1) does this test applicable to new food/ beverage ? What is the spec/ guideline we can use to determine the sample still good to consume after x days?

[@pharmasolutionpakistan7668]

Very informative

[@karnakarkadaru2317]

Your lecture not elaborate the procedure not cover the approaches if we got Excursions and significant changes