Regulatory Roundup: ICH Draft Residual Solvents Guideline Published; And More. - Pharmaceutical Technology

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Regulatory Roundup: ICH Draft Residual Solvents Guideline Published; And More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA published this week as a draft recommendation the Step-2 version of the International Conference on Harmonization’s Q3C(R5) Guideline on Residual Solvents to account for new toxicity data related to cumene (Cumol; isopropylbenzene; isopropylbenzol; (1-methyl/ethyl)benzene; 2­Phenylpropane). ICH finalized and approved Q3C(R4), the fourth revision to this guideline, in July 2007. This Step-2 guideline represents a fifth revision, which ICH issued in the form of a final concept paper in June 2009 and approved in March 2010. In Q3C(R4), cumene is listed as a Class-3 solvent in ICH's table of residual solvents. The fifth revision aims to place cumene into Class 2 based on new toxicity data.


The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), has released a Quality Agreement template designed for the custom manufacture and release of active pharmaceutical ingredients (APIs). The organization released a general API Quality Agreement Template in May 2010. The templates are meant to help manufacturers, suppliers, and distributors comply with current regulations, including the International Conference on Harmonization Q7 guideline, by putting into place standardized quality agreements.


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