FDA's Rollout of New Inspection Protocols May Begin Next Year
Despite great enthusiasm within the agency for a New Inspection Protocols Pilot Project, FDA officials are saying they don't expect to adopt the protocols for broader use in pharmaceutical facility preapproval and surveillance inspections until perhaps sometime in 2017. The protocols could make inspections more comparable – and could bring recognition to facilities that go beyond compliance.
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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.
By the end of next year, new FDA protocols could bring more consistency from one inspection to the next and from one investigator to another.
How will FDA investigators advance from today’s highly variable ‘traffic ticket’ inspection approach to tomorrow’s super consistent, semi-quantitative ‘state of quality’ assessments? The answer: A new inspection protocol project that FDA officials have been describing at recent conferences.