The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Inspection of Injectable Products for Visible Particulates
Internet:
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
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