The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance Q3C(R8) for determining new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The recommendations were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of patients and will be available for public comment under Docket No. FDA-2020-D-1301. This guidance reflects just one element in FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. FDA publishes ICH guidelines as FDA guidance and is committed to seeking scientifically based harmonized technical procedures for the development and manufacture of pharmaceuticals. |
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