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.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• 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.

Target Audience (If applicable):
– Analytical scientists
– QA/QC
– Formulators,
– Manufacturing scientists
•CMC submission and review scientists
– Regulatory professionals