Objectives of the Presentation:
Upon completion of this course the learner should be able to:
1) Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
2) Understand what specifications will conform to regulatory expectations
3) Develop an process for reporting impurities and addressing OOS situations
Areas Covered:
- Landscape of impurities requiring control in pharmaceutical products
a. General impurities: elemental impurities, residual solvents, microbiological
b. Drug-related impurities: process impurities, degradants, potentially genotoxic impurities
- Process Impurities
a. Understanding ICH Q3A
b. Where impurities originate
c. How impurities are characterized
d. How specifications are developed
e. How impurities should be reported
- Degradants
a. Understanding ICH Q3B
b. Where degradants originate
c. How degradants are characterized
i. Potential genotoxic impurities
d. How specifications are developed
e. How degradants should be reported
- What to do if an Out of Specification result is generated
Who will benefit:
Chemists, Supervisors and Laboratory Managers (Research, Quality Control, CRO) and Quality Assurance personnel involved with generating and reporting impurity results, and regulatory affairs/CMC personnel responsible for documenting compliance with impurity requirements.
Why you should attend:
The control of drug-related impurities can be the source of much anxiety, including the establishment of specifications and during release and stability testing of subsequent samples. This course will help you to understand the expectations, and give practical advice for setting specifications and for addressing issues during routine testing.
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.