title: Compliance program for auditing the Chemistry, Manufacturing and Controls section of NDAs and ANDAs.
authors.affiliation: Du Pont Merck Pharmaceutical Company, Wilmington, DE.
authors.forename: R C
authors.initials: RC
authors.lastname: Stellon
authors.forename: E M
authors.initials: EM
authors.lastname: Sullivan
mesh_terms: D017277:Drug Approval; D004345:Drug Industry; D008330:Management Audit; D014481:United States; D014486:United States Food and Drug Administration