This course will cover the main aspects related to the control of impurities in drugs and medicines and the application of the USP –NF General Chapter <1086> Impurities in Drug Substances and Drug Products. The content will consist of forced degradation studies that assist in the identification of the most likely degradation products. Case studies will demonstrate degradation pathways, intrinsic stability of the molecule and validation of the analytical procedures.

Subject area:
Drug Products & APIs

Objectives (If applicable):
•Compare regulatory versus development guidance
•Explain regulatory guidance for impurities
•Describe the fundamentals of oxidative degradation
•Identify and apply best practices for oxidative stress testing
•Describe the fundamentals of photochemistry
•Identify and apply best practices for photostability testing
•Explain the importance of stress testing conditions
•Identify forced degradation data in regulatory filings
•Explain considerations for applying ICH M7 guidance to product development
•Apply ICH and regulatory guidance to case studies

Target Audience (If applicable):
•Research and Development
•QA/QC Staff
•Regulators
•Regulatory Affairs Specialists