Ich guidelines for extractables and leachables

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Most research on Extractables and Leachables is done on dosage forms that come with a high risk, like inhalation products, injectables, ophthalmics products A new guideline on the assessment and control of extractables and leachables (E&L) is proposed. ICH has developed guidelines covering many ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics. Work on the ICH Q3E impurity However, it has been evident that for decades the guidance for E&Ls wasn't aligned with the safety based impurity guidance on other specific impurities, e.g. guidance for extractables and leachables testing. ➢2014 ICH Q3D “Guideline for Elemental Impurities” (Step 4). ➢2014 Draft USP <661> “PlasticThe Q3C ICH Guideline was finalised under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances