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ISPE APQ Guide: Management Responsibilities & Review (MRR)

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Merknad: Denne standarden har en ny utgave: ISPE APQ Guide: Cultural Excellence

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Omfang

ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating 'strong and visible support for the pharmaceutical quality system." The ISPE APQ Guide: Management Responsibilities and Management Review provides a quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 as well as other key leadership components:Patient/Consumer FocusManagement CommitmentQuality PlanningInternal CommunicationManagement of Outsourced Activities and Purchased MaterialsManagement of Change in Product OwnershipRegulatory and Industry Awareness

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  • Varetype: IS
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