Greater clarity on visual inspection programs for parenteral drugs covered by the US Pharmacopeia’s new Chapter <790> may be the reason why FDA investigators have been finding fewer problems in this area over the past few years, industry officials said. Yet new observations are cropping up for inadequate sampling plans for visual inspections.
The new chapter, called “Visible Particulates in Injection,” clarifies testing conditions and sets acceptable and unacceptable quality limits for particles, John Shabushnig, principal consultant with Insight Pharma Consulting, said Sept. 13 at the Parenteral Drug Association/FDA Join Regulatory Conference in Washington