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Research ArticlePDA Papers

Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction

Emma Ramnarine and Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 338-345; DOI: https://doi.org/10.5731/pdajpst.2017.008524
Emma Ramnarine
Sr. Director, Head Global Analytical Science and Technology, Genentech/Roche
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  • For correspondence: eramnar@gene.com
Kevin O'Donnell
Market Compliance Manager, Health Products Regulatory Authority (HPRA)
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Abstract

Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. This paper introduces the concept of evidence-based risk reduction within the continual improvement framework. It presents how regulatory relief and flexibility in post-approval change management and overall product lifecycle management can likely only be achieved via (1) effective application of science and risk-based concepts and (2) demonstrated effectiveness of the pharmaceutical quality system in assuring a state of control.

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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 3
May/June 2018
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Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
Emma Ramnarine, Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 338-345; DOI: 10.5731/pdajpst.2017.008524

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Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
Emma Ramnarine, Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 338-345; DOI: 10.5731/pdajpst.2017.008524
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  • Article
    • Abstract
    • Introduction
    • Practical Implications
    • Risk Management and Knowledge Management
    • Role of the Pharmaceutical Quality System (PQS)
    • Estimation of Risk Reduction
    • Change Management and Risk Reduction
    • Enabling Regulatory Flexibility through an Effective PQS
    • Risk Management Learnings from Other Industries
    • Conflict of Interest Statement
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  • Achieving “Zero” Defects for Visible Particles in Injectables
  • PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
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