Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review

Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review cover image

Title:

Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review

Author(s):

Cromwell, Tisha; Frederick, Tami; Goldfinger, Marci; Greer, Steven; Grischeau, Michael; Matje, Robert; McClain, Lorraine; Valentino, Jo Anne; Walcott, Veda K.; Winship, Bryan

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Author(s): Cromwell, Tisha; Frederick, Tami; Goldfinger, Marci; Greer, Steven; Grischeau, Michael; Matje, Robert; McClain, Lorraine; Valentino, Jo Anne; Walcott, Veda K.; Winship, Bryan

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

The ISPE APQ Guide: Management Responsibilities and Management Review is the second publication in the APQ Guide series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity.

Note:Each Guide in the APQ Guide series contains two parts. Part 1 covers the key principles of the APQ program and explains the Assess, Aspire, Act, and Advance framework. This prerequisite information is applicable to all PQS elements and is common across each of the APQ Guides. Part 2 of the ISPE APQ Guide: Management Responsibilities and Management Review covers the practical application of the APQ framework to leadership.

Table of Contents

Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review

Full Title: ISPE Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review
Pages: 162
Published: 2021-07-23