FDAnews Drug Daily Bulletin

Facing Gaps in Supplier Quality Audits? Beef Up Incoming Acceptance Activities: Expert

Aug. 3, 2012
While drugmakers should not rely on a ‘Plan B’ for validating suppliers, there are some steps they can take if they can’t conduct sufficient quality audits — primarily beefing up incoming acceptance activities, compliance experts say. The FDA generally expects companies to link supplier management with incoming acceptance activities, Denise Dion, vice president of regulatory and quality services at EduQuest and a former agency field inspector, said Wednesday.
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