mdi ConsultantsVisible Particulates Can Harm Patients – FDA Announces a More Holistic Screening Approach for Safety
The U.S. Food and Drug Administration is announcing the draft guidance for industry entitled “Inspection of Injectable Products for Visible Particulates.”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 This draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control.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).
For more information on the FDA guidance for Visible Particulates, and/or this recall, please email us at: [email protected] and ref: Visible Particulates.