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FDAnews Drug Daily Bulletin
Aug. 10, 2012 | Vol. 9 No. 157
FDA: Use Our Inspection Checklist When Auditing CMOs
TAMPA, Fla. — What’s the best way to audit a contract manufacturer for initial qualification or ongoing compliance? Start with the same documents the FDA wants to see when it begins an audit, CBER investigator Pam Trost says. In addition, drugmakers should review the contract manufacturing organization’s standard operating procedures, quality management systems and the training and qualification of staff. “You may not get everything you ask for during an audit, but you can still ask,” Trost told the audience Wednesday at the GMP By the Sea conference here.
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