Article

De-Risking Visible Particles Through Component Selection

Source: West Pharmaceutical Services, Inc.

By John Rech

GettyImages-1330728771-microscope-lab

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.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 The draft guidance is titled “Inspection of Injectable Products for Visible Particulates” to clarify the various areas where controls must be in place in order to have a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This article is a summary of the FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Drug Delivery Leader? Subscribe today.

Subscribe to Drug Delivery Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Drug Delivery Leader

West Pharmaceutical Services, Inc.