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Modernizing USP Organic Impurities Standards

 
USP Expert Panel on Modernization of Organic Impurities Testing in Drug Substances and Drug Products is in the process of modernizing the USP chapters on organic impurities.  The panel is in the process of revising USP General Chapter <1086>.  The revisions align the USP chapter with current regulatory guidelines for over-the-counter and for generic products, which also references General Chapter <466> Ordinary Impurities and General Notices 5.60.  Revisions also harmonize terminology and principles with ICH Q3A and Q3B.  The Expert Panel is also creating a new mandatory chapter, <476> Organic Impurities in Drug Substances and Drug Products, including acceptance criteria aligned with the organic impurity thresholds established in ICH guidelines.  Chapter <476> will support those monographs that do not include specific impurity tests and those monographs that need additional guidance.

A workshop in September 2011, co-sponsored by USP and FDA on over-the-counter drugs and a survey by USP in June 2013 of current stakeholders led to the creation of an Expert Panel charged with the revision of <1086> (informative chapter) and the development of a new chapter <476> (mandatory chapter).  A Stimuli article, in-process revisions of the general chapter <1086> and the new chapter <476> were published in the Pharmacopeial Forum 40(3).  Revised drafts of the two chapters consolidating public comments were published in Pharmacopeial Forum 41(3). Now, a set of revised drafts will be published in an upcoming version of Pharmacopeial Forum.  Watch for drafts to be published by year end 2017.

Key Contacts:

Antonio Hernandez-Cardoso, Senior Scientific Liaison, USP

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