FDA Launches Protocol For Inspections Of Sterile Drug Manufacturing Facilities
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.
You may also be interested in...
The US FDA announces plans to expand its new protocol-based approach to inspections, NIPP, to non-sterile drugs and provides glimpse of what metrics the agency is using to measure pharmaceutical quality during inspections.
Head of US FDA's Office of Pharmaceutical Quality says agency doesn't want pharmaceutical companies to know just how they will be inspected under the emerging standardized 'NIPP' approach, lest they use that knowledge to game the process.
US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.