Strategies for Compliance with Changing USP Expectations Two major changes have been proposed to the USP pertaining to “Heavy Metals” - <231> and “Containers” - USP <661>. The current versions of both monographs utilize antiquated analytical techniques developed before the 1960’s. As identified in 1995, <231> cannot differentiate between safe and unsafe products.
The current “Containers” monograph makes compliance to the quality standard reliant on non-discriminatory tests which cannot predict leachables. Under the current implementation schedule, compliance with new chapters “Elemental Impurities – Limits” - <232> and “Elemental Impurities – Procedures” - <233> will be required by December 1, 2015.
James W. McLean, M.S.,
Manager, Extractables & Leachables
James is the Manager of the Catalent Extractables and Leachables Analysis group at the Morrisville, North Carolina site. He has provided the group’s leadership for over 5 years. Prior to joining the E&L Analysis group, James was the key subject matter expert on cleaning validation for Cardinal Health. He holds a BS and an MS from the University of North Carolina at Chapel Hill.
Michelle E. Cree, Ph.D.,
Manager, Strategy & Business, Elemental Impurities
In 2007 Michelle joined Catalent Pharma Solutions to develop the Inorganic Analysis team. Currently the team specializes in development and validation of methods for determination of elemental impurities in API, excipients and finished product as well as characterization of container closure systems for inorganic impurities, simulation studies and assessment of inorganic leachables.
- Learn drivers for changes to USP <231> and <661>
- Understand requirements for timely compliance to USP <232> and <233>
- Understand requirements and structure for USP <661>, <1663> and <1664>
- Key tools for developing your individual compliance strategy
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