De-Risking Visible Particles Through Component Selection

By John Rech

Adverse events can be associated with the injection of visible particulate and are dependent on the route of administration and patient population, among other things, and can result in infection, emboli, granulomas, phlebitis and more.⁵ Control of visible particle is essential under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in order to prevent a drug product from becoming adulterated. The draft guidance is titled “Inspection of Injectable Products for Visible Particulates” to clarify the various areas where controls must be in place in order to have a successful particle control strategy that meets the regulatory expectations set forth in USP <790>⁴ and the associated cGMP regulations.

This article is a summary of the FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.