APQ Guide: Management Responsibilities & Review (MRR)
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
Product Details
- Published:
- 07/01/2021
- Number of Pages:
- 162
- File Size:
- 1 file , 12 MB
