Course Description:This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP’s approach to impurities in monographs. It also provides insights to USP‒NF General Chapters <476> and <1086> and include case studies for impurities in the development and revision of USP monographs.
Upon completion of this course, you will be able to:
- Discuss the origin and classification of impurities in pharmaceuticals.
- Explain global guidance's for impurities.
- Describe the USP approach to impurities in drug substances and drug products.
- Discuss the USP general chapters on impurities.
• - Explain the USP approach to harmonization across pharmacopeia.
- Demonstrate knowledge of USP’s approach for impurities in documentary standards via case studies.
Who should participate:
- Analytical scientists
- QA/QC
- Formulators
- Manufacturing scientists
- CMC submission and review scientists
- Regulatory professionals
Access Duration:
Access to this course expires 6 months 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 on-demand course, were official as of this date. Please check www.uspnf.com for relevant updates.
The "Impurities in Drug Products and Drug Substances - A USP Approach" USP Education course benefits from our extensive PAI catalog of over 740 impurities, including new NDSRIs and impurities associated with USP-NF Monographs.
View all Nitrosamines RS in USP Store – Includes over 65 Nitrosamines RS
USP Approved Instructor
Christian Zeine, PhD.,
Senior Manager Scientific Affairs, EMEA
The United States Pharmacopeia
Ph.D. in Silicon-Organic Chemistry,Westphalian Wilhelms University Muenster, DE