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Residual Solvents: Take Advantage of the New Flexibility in Revised USP 467

Summary

  • Understand the requirements for residual solvents addressed in ICH, USP, EP and JP.
  • Take advantage of the flexibility introduced in the revisions to USP <467>
  • Utilize strategies to minimize the testing and resources required to meet the requirements
  • Verify the USP procedure (or validate alternatives) in accordance with expectations
  • Regulatory Landscape for Residual Solvents: ICH, USP, EP and JP
  • Revision to USP <467>: improved clarity and flexibility
  • Discussion on various approaches to compliance, and how to minimize resources
  • Unresolved issues: solvents with poor volatility or not yet addressed
  • Questions and Discussion

Overview

This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.

This course focuses on recent changes to USP <467> which can increase flexibility and reduce workload for testing of residual solvents in raw materials and finished products. It addresses options such as whether to test raw materials or drug products, whether to use USP or alternate testing methods, when to screen for all solvents and when to test for specific solvents. Significant resources can be saved by reduced testing, and we discuss the steps necessary to do this successfully.

Who should attend?

  • Quality Control Personnel
  • R&D Scientists
  • Laboratory Supervisors and Managers
  • Quality Assurance Personnel
  • Chemists/Managers
  • CMC or Regulatory Affairs Personnel

Gregory Martin

Expert

Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. 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. 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.

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