Navigating General Chapter <467> Residual Solvents

Background

As part of its mission to provide the standard for manufacturing, U.S. Pharmacopeia has worked closely with industry and the FDA to resolve the impact and ensure uniformity of application to the new ICH Q3C approach to Residual Solvents. The implementation of the new approaches is demanding and complex with many factors to be considered and understood. While manufacturers do have the option of testing their finished goods, the existing methodologies are cumbersome and expensive, and the responsibility for compliance will be extended beyond the finished good manufacturer to their suppliers.

Course Description

Proving a broad understanding of the new requirements, the course addresses identification, control and quantification of residual solvents. Instruction will provide information on the ingredients and products effected by the new standard, the testing and validation practices that will be accepted as well as procedures to document compliance.

Format

Web Based Education (WBE)

Learning Objectives

  • Full understanding of how the hierarchy of the USP/NF was used to implement changes to residual solvent determination.
  • Understand the risk analysis and options to comply with the chapter.
  • Emphasize that USP methods should be used when at all possible; if not then new methods can be developed and communicated.

Contact Information

Contact USP Customer Service to register, 1–800–227–8772 or