Chemical and physical changes of Active Pharmaceutical Ingredients (API) and drug products can affect both safety and efficacy of the drugs. These changes can cause the increase of organic impurities or formation of new impurities. Therefore, monitoring impurities is considered a critical activity of analytical development to ensure quality of the pharmaceutical products.

This session will discuss the requirements of ICH Q3A/B for monitoring impurities in API and drug products, practical considerations when examine impurities, how they are reported in regulatory documentation, and key factors to consider when setting impurity specifications.  In addition, it will also discuss development strategies to understand the impurity profile of a drug product and how they should be monitored (and controlled) to ensure quality of drug products be maintained during the development as well as into commercial phases.  A discussion on the USP Chapters and USP initiatives on organic impurities.

Course Objectives:

Upon completion of this session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities.  Participants will gain practical knowledge about key considerations when reporting impurities for regulatory submission.  This session will also discuss observations and infractions that were obtained related to monitoring impurities in pharmaceutical labs.

Course Outline:

• Understand regulatory expectations
• Discuss warning letters and citations
• Understand regulatory requirement guidelines surrounding impurities in API and Drug Products
• Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products
• Understand different thresholds to report in regulatory submission
• Development considerations to establish impurity profile
• Control strategies to monitor impurities in drug product
• Discuss the USP initiatives on organic impurities

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Analytical chemists
• QC managers
• QC analysts
• QA managers
• Compliance managers
• Lab managers
• Sale managers
• Manufacturers of raw materials and ingredients
• Regulatory scientists, and individual personnel, who are working in pharmaceutical development.