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Guidance for Residual Solvents: Q3C(R8) Impurities

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and released on 10 December 2021.

This guidance provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. \

This guidance is intended to recommend acceptable amounts for these residual solvents in pharmaceuticals for the safety of the patient. As part of the maintenance process for the ICH guidance for industry Q3C Impurities: Residual Solvents (December 1997), the Q3C PDE levels are added and revised as new toxicological data for solvents become available.

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Inspection of Injectable Products for Visible Particulates- Draft Guidance -USFDA

Also On 17 December, the U.S. Food and Drug Administration announced the draft guidance for industry entitled "Inspection of Injectable Products for Visible Particulates." Visible particulates in injectable products can harm patients.

This draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control. This approach incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination.

The guidance clarifies meeting an applicable United States Pharmacopeia compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for manufacturing injectable products. Manufacturers must fully comply with CGMP requirements to ensure the continued supply of safe, effective, and high-quality injectable products. The guidance does not cover subvisible (too small to be visible to the unaided eye) particulates or inspection for physical defects during inspection for visible particulates (e.g., container integrity flaws, fill volume, appearance of lyophilized cake/suspension solids).


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