APQ Guide: Management Responsibilities & Review (MRR) PDF

APQ Guide: Management Responsibilities & Review (MRR) PDF

Name:
APQ Guide: Management Responsibilities & Review (MRR) PDF

Published Date:
07/01/2021

Status:
Active

Description:

Publisher:
International Society for Pharmaceutical Engineering

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Czech version):
200 business days

SKU:
apq-guide-management-responsibilities-review-mrr_2229360

Choose Document Language:
154.50
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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

File Size : 1 file , 12 MB
Note : This product is unavailable in Russia, Belarus
Number of Pages : 162
Published : 07/01/2021

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