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APQ Guide: Management Responsibilities & Review (MRR)

$257.50

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

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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 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