FDA Guidance for Industry: Inspection of Injectable Products for Visible Particulates
Title:
FDA Guidance for Industry: Inspection of Injectable
Products for Visible Particulates
Origin/Publisher:
FDA
Content:
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