FDA Taking Closer Look at Manufacturers’ Visual Testing Programs While USP Would Set New Limits for Particles

24 Oct 2013

• By Joanne S. Eglovitch

FDA investigators are taking a closer look at parenteral manufacturers’ inspections for visible particles while a proposed USP standard would give more guidance – and much needed clarity – on establishing acceptable quality limits for particles and setting up visual inspection programs.

FDA investigators are taking a closer look at parenteral drug manufacturers’ inspection programs for visible particles, while proposed U.S Pharmacopeia standard <790> would establish acceptable and unacceptable quality limits for particles and give industry more guidance – and much needed clarity – on setting up visual inspection programs.

In the absence of these standards, there are differing viewpoints, and much confusion, on what to do once particles are...