FDA Launches Protocol For Inspections Of Sterile Drug Manufacturing Facilities

12 Nov 2018

US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.

Investigators in Clean Room — FDA INVESTIGATORS INSPECT A PHARMACY CLEANROOM • Source: US Justice Department

The US FDA's surveillance and pre-approval inspections of sterile drug manufacturing facilities are likely to be more consistent, streamlined and effective now that the agency is rolling out a protocol it has piloted for them.

The aseptic processing inspection protocol announced Nov. 9 is the first of several the agency plans to establish over the...