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Review ArticleReview

Points to Consider When Using KPIs/Metrics

Bernhard Hinsch, Sven Alexander Moritz, Ana Esteban Nunez, Timothy E. Orszula, Daniel Taylor and Alexander Nezlin
PDA Journal of Pharmaceutical Science and Technology January 2022, 76 (1) 75-87; DOI: https://doi.org/10.5731/pdajpst.2020.012401
Bernhard Hinsch
1Hinsch Consulting, Berlin, Germany;
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Sven Alexander Moritz
2Sanofi-Aventis Deutschland GmbH;
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Ana Esteban Nunez
3Compliance Division, Pfizer;
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Timothy E. Orszula
4External Commercial Quality Assurance, Alkermes;
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Daniel Taylor
5Corporate Quality, Astra Zeneca; and
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Alexander Nezlin
6UroGen Pharma
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Abstract

Pharmaceutical quality systems according to ICH Q10 require the identification of processes that need to be measured. Designing and maintaining a metrics system in a way that serves its purpose well requires careful consideration of various aspects in order to meet expectations. The purpose of using key performance indicators/metrics can be defined by main aspects that include: 1) supporting the achievement of objectives by making them measurable, 2) reaching comparability and/or standardization of performance for organizational units, and 3) achieving objectiveness in assessing performance. The first two aspects are closely linked to management responsibilities. Therefore, management needs to be strongly involved with the activities of setting up and maintaining a metrics system. This article provides an overview of the points to be considered when setting up and managing a quality-related metrics system.

  • KPIs/Metrics
  • Quality Management Review
  • Quality System
  • Scorecard
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 1
January/February 2022
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Points to Consider When Using KPIs/Metrics
Bernhard Hinsch, Sven Alexander Moritz, Ana Esteban Nunez, Timothy E. Orszula, Daniel Taylor, Alexander Nezlin
PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 75-87; DOI: 10.5731/pdajpst.2020.012401

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Points to Consider When Using KPIs/Metrics
Bernhard Hinsch, Sven Alexander Moritz, Ana Esteban Nunez, Timothy E. Orszula, Daniel Taylor, Alexander Nezlin
PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 75-87; DOI: 10.5731/pdajpst.2020.012401
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Purpose of KPIs/Metrics
    • 3. Essential and Desirable Features of KPIs/Metrics
    • 4. Areas of Application
    • 5. Categorization
    • 6. Example Definitions
    • 7. Visualization
    • 8. Points to Consider
    • Conflict of Interest Declaration
    • Acknowledgments
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