WelcomeStability profile is determined to be the critical quality attributes of drug substance and drug products. This course is intended to provide a basic to advanced level understanding on developing a stability program to support the expiration dating of pharmaceutical products. Content will focus on different aspects from development to commercial to understand the stability profile of drug substance and drug products. In addition, a thorough update of recent and emerging techniques used to establish the integrity, strength, quality and purity of drug products will be provided.
Course ObjectivesAfter completing this online course, the user will be able to:
- Identify and discuss the current regulations globally required for a stability program to support expiration dating and use periods of drug products/API
- Describe requirements for stability indicating methods
- Monitor impurities in API and drug products
- Identify/set stability specifications and change controls
- Review, evaluate and discuss stability data
- Create a stability report and CMC documents
- This course is identified as a knowledge educational activity.
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