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.

Subject area:
Excipients

Objectives (If applicable):
• 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 Excipient General Chapters
• Summarize important elements of:
o USP–NF General Chapters <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients,
o <1195> Significant Change Guide for Bulk Pharmaceutical Excipients
o <1080> Bulk Pharmaceutical Excipients – Certificate of Analysis.

Target Audience (If applicable):
• Analytical scientists
• Excipient manufacturers
• Compounding pharmacy staff
• Quality assurance
• Quality unit personnel
• Pharmaceutical scientists
• Regulatory professionals
• Chemistry and manufacturing control Reviewers