Course Description:This session will examine the development of General Chapters <312> to <316> as modern analytical tools for use with individual monographs. The discussion will highlight key considerations for implementation and the importance of staying current with evolving standards.Further discussion will focus on implementing compendial strategies and industry best practices for excipient standards. Participants will learn effective approaches for establishing meaningful specifications that ensure consistent excipient performance and product quality.This session will also explore USP's holistic approach for Lactide-Glycolide or Lactic Acid-Glycolic Acid (LG) polymers, functionality of LG Polymers, and drug product performance. Participants will gain insight into the specific requirements for polymeric materials used in pharmaceutical applications, including recent updates to relevant USP chapters. The discussion will cover implementation strategies for emerging standards, interpretation of test methods, and approaches for demonstrating compliance when standalone general chapters are applicable to polymer-based excipients.
Who should participate:
- Professionals in Research & Development
- Product Development
- Formulation
- Excipient Manufacturing
- Regulatory Affairs
- Quality Control
- Commercial Management
- Government Relations
- Supply Chain Management
- Quality Assurance
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.