Course Description:This course will explore the nature of excipients and how they differ from active pharmaceutical ingredients and pharmaceutical finished products. An introduction to excipients and review of USP–NF General Chapters related to pharmaceutical excipients will be covered. An explanation of recent updates and developments to excipient GMP chapters will also be covered. Real-world scenarios will be used to apply USP General Chapters information along with some industry best practices and guidance.
Upon completion of this course, you will be able to:
- Demonstrate knowledge of what pharmaceutical excipients are and what they are not.
- Identify differences and diversities associated with pharmaceutical excipients.
- Describe reasons for using pharmaceutical excipients.
- Explain the significance of USP General Chapters relevant to excipients.
- Summarize important elements of:
- USP–NF General Chapters <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients
- USP–NF General Chapter <1195> Significant Change Guide for Bulk Pharmaceutical Excipients
- USP–NF General Chapter <1080> Bulk Pharmaceutical Excipients – Certificate of Analysis
Who Should Participate:
- Analytical scientists
- Excipient manufacturers
- Compounding pharmacy staff
- Quality assurance
- Quality unit personnel
- Pharmaceutical scientists
- Regulatory professionals
- Chemistry and manufacturing control Reviewers
The live version of this recording took place on June 11, 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.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Irwin Silverstein, PH. D.
USP General Chapters-Excipients Expert Committee
USP Verification Program Auditor