Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements April 10, 2013

This training will discuss regulatory requirements for monitoring of pharmaceutical impurities. It will explain how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and to measure the thresholds to report for regulatory submission.

Why Should You Attend:

Monitoring impurities is considered a critical activity of analytical development in order to ensure the quality of the pharmaceutical products. Current ICH Guidelines indicate that the measurement of impurities should always be conducted for active pharmaceutical ingredient (API) and its drug 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.

Learning 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 due to recoding impurities in pharmaceutical labs.

Areas Covered in the Seminar:

- 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 for regulatory submission.