FDA investigators will be looking for more transparency between a sponsor and its contract sites regarding the sponsor’s drug application commitments and the contractor’s plant-wide GMP status, FDA Cincinnati District Investigator and Preapproval Manager Kathleen Culver emphasized at a Global Outsourcing Conference at Xavier University on June 14.
Drug firms that outsource manufacturing and testing activities should share the appropriate sections of their drug applications with the contract firms to avoid misunderstandings, facilitate site compliance with the commitments in the application and aid review and pre-approval inspections, Culver emphasized. “I am looking for this when I do the pre-approval inspection to assure there are no misunderstandings and that we will not end up with adulterated or misbranded drug product,” she explained.
In turn, where the contract firm manufactures for multiple clients, it is important that the sponsor have access to other client’s audit findings and records that shed light on the contractor’s overall quality system, Culver stressed. “How can you really thoroughly audit a GMP system when you cannot review all the deviations, investigations or data generated in that system?” the FDA investigator asked. She stressed the importance of performing thorough audits of the quality systems during the contract manufacturer selection process.
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