Guide on Inspecting Injectables for Particulates

FDA has released a draft guidance entitled Inspection of Injectable Products for Visible Particulates. The document 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.” It also notes that meeting an applicable United States Pharmacopeia compendial standard alone is not generally sufficient for meeting GMP requirements for manufacturing injectable products. The guidance, however, does not cover subvisible (not seen with the naked eye) 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).