Residual Solvents: Understanding the Requirements and Practical Advice for Implementing USP <467>/ICH Q3C

Why Should You Attend:

This webinar is designed to provide participants with an understanding of the regulatory landscape for residual solvents requirements, including interpretation of the majors sections (classes of solvents, options for describing levels, analytical procedures). It will discuss controlling residual solvents in incoming materials as well as those introduced during manufacture. It will review analytical procedures for testing of residual solvents and discuss strategies for compliance and reporting of residual solvents levels. Several frequently asked questions will be addressed, after the presentation there will be an opportunity for questions and discussion.

Learning Objectives:

Upon completion of this course the participants will be able to:

• Understand the requirements for residual solvents addressed in ICH, USP, EP and JP.
• Identify the classes of solvents and address sources of solvents.
• Utilize strategies to minimize the testing and resources required to meet the requirements.
• Select appropriate analytical procedures when testing is necessary.
• Report levels of residual solvents appropriately.

Areas Covered in the Webinar:

• Introduction: Regulatory Landscape for Residual Solvents
• Implementation and Strategies for Compliance: Testing and Avoiding Testing
• Analytical Procedures for Residual Solvents: Compendial Procedures, Alternative Procedures and Reference Standards
• Reporting Residual Solvents: Assuring You Address Regulators’ Concerns
• Questions and Discussion

Who Will Benefit:

This webinar will provide valuable assistance to all drug companies/ manufacturing sites.Those that would benefit most would be:

• Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers,
• Regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements
• Laboratory managers and staff
• Analysts
• QA/QCU managers and personnel
• Training department
• Documentation department
• Consultants

Instructor Profile:

Gregory 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 Past 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. He can be contacted at [email protected].

Topic Background:

Compliance with compendial standards for residual solvents is required for all drug products provided in the United States, and similar requirements exist in all the major markets of the world. Since every product is unique, and since the requirements refer to over 50 different solvents, achieving compliance can be very challenging. Many, many firms have received incomplete or warning letters from the FDA as a result of failure to adequately address the reporting of residual solvents.

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