Companies With Gaps in Supplier Audits Should Beef Up Incoming Acceptance

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. Her comments came at FDAnews’ Supplier Quality Management Congress in Bethesda, Md.
Washington Drug Letter