APQ Guide: Management Responsibilities & Review (MRR)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2021

Full Description

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

Product Details

Published: 07/01/2021 Number of Pages: 162 File Size: 1 file , 12 MB