Inspection of Injectable Products for Visible Particulates Draft Guidance for Industry December 2021

GUIDANCE DOCUMENT

• Docket Number: FDA-2021-D-0241
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Veterinary Medicine

Visible particulates in injectable products can jeopardize patient safety. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that 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 also clarifies that meeting an applicable United States Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products. The guidance does not cover subvisible particulates or physical defects that products are typically inspected for along with inspection for visible particulates (e.g., container integrity flaws, fill volume, appearance of lyophilized cake/suspension solids).

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