Practical Applications of Chapter <467> Residual Solvents

Background

Implementation of the new USP requirements on testing for residual solvents in drug substances, products, and excipients became effective on July 1, 2008. Designed to harmonize with the International Conference for Harmonization (ICH), USP General Chapter <467> significantly increases the number of solvents for which a company must screen.

Course Description

USP is presenting this one-day lecture that moves beyond an overview of the new requirements focusing on implementation issues in the lab. Analytical procedures contained in Chapter <467> and alternative testing protocols will be covered, as well as common points of confusion and concerns encountered by the industry. A question and answer period is included to address the specific inquires of attendees.

Who Should Participate

Laboratory supervisors, bench chemist and compliance staff in parenteral drug manufacturers, ophthalmic solution manufacturers with less than 5 years of experience

Format

Classroom, Full day, Lecture only

Learning Objectives

  • Review Guidelines contained in Chapter <467>
  • Discuss common mistakes and misconceptions
  • Illustrate Option 1 and 2, as well as procedures A, B, and C
  • Introduce risk-based strategy concept when dealing with compliance issues
  • Explain how to develop and validate alternative methods

Contact Information

For additional information, contact