From The Corner Lab - Blog Posts

New Guidance Available for Elemental Impurities: Meeting Compliance with USP, ICH Q3D, FDA and GMP Requirements.

Posted by Jim Menoutis on Tue, Oct 27, 2015 @ 02:01 PM

A new guide is available covering meeting compliance with USP<232> & <233>, ICH Q3D, FDA’s and GMP requirements. The guide details time lines for compliance, including FDA and EQDM/EMA deadlines for both existing and new drug products. In addition to covering USP’s requirements , it also provides an in depth analysis of FDA’s requirements for complying with ICH Q3D. The guide also covers what will be needed to demonstrate compliance with elemental impurities during FDA GMP inspections.  Click Here to Download


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Topics: USP, cGMP, USP <232>, FDA, ICH, Q3D, FDA ANDA,