APQ Guide: Management Responsibilities & Review (MRR) PDF

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 Focus
• Management Commitment
• Quality Planning
• Internal Communication
• Management of Outsourced Activities and Purchased Materials
• Management of Change in Product Ownership
• Regulatory and Industry Awareness