Course Description:
USP General Chapter <477> which becomes official on May 1, 2024, provides users a risk-based, flexible approach for determining the reporting thresholds for organic impurities, aligned with their product-specific implementation of a monograph test procedure. Detailed information in USP General Chapter <477> will be discussed on the topics below:
- Alignment with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3A and Q3B guidelines expectations
- Product considerations
- Routes of administration
- Maximum daily dose
Who should participate:
- Users of chemically synthesized DS and/or DP Monographs
- Analytical Chemists
- Laboratory managers
- QA/QC staff/managers
- Managers
- Directors
- Production Managers
- Compliance managers,
- Compendial affairs personnel
- All pharmaceutical professionals/academicians interested in organic impurities in DS and Drug Products
The live version of this recording took place on January 31, 2024
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker
Nick Garito
Senior Principal Scientist, Small Molecules, USP
B.Sc. degree in Chemistry from the Virginia Polytechnic Institute and State University
Antonio Hernandez-Cardoso
Senior Principal Scientist
General Chapters, USP
B.Sc. and M.Sc. degrees in Pharmaceutical Chemistry from the National Autonomous University of Mexico