title: The changing role of quality assurance in the pharmaceutical industry.
abstract: ICH Q10. Pharmaceutical Quality System emphasizes that senior management is responsible for the quality system. Thus, it is not the quality assurance organization that has the primary responsibility for the quality system. With this shift of responsibilities, what can quality assurance do to help senior management fulfill their responsibility? How can quality assurance be more proactive, add more value? What new skills does quality assurance need to have in order to perform its new role? This article attempts to answer these questions.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Kieffer
mesh_terms: D004345:Drug Industry / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards; D011786:Quality Control
keywords: ICH Q10; QA; Quality assurance; Quality system; Senior management