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Beyond Batch Release: Responsible Decision-Making, Professional Judgment, and Governance in Complex Pharmaceutical
1Independent Pharmaceutical Consultant and Qualified Person (QP) mmhstassen@gmail.com.
PDA Journal of Pharmaceutical Science and Technology
|April 18, 2026
Summary
Responsible decision-making in pharmaceutical manufacturing requires more than compliance. Professional judgment, integrated expertise, and patient-relevant quality are crucial for navigating complex, evolving environments.
Area of Science:
- Pharmaceutical Manufacturing
- Regulatory Science
- Decision Science
Background:
- Modern pharmaceutical manufacturing involves complex, rapidly evolving environments.
- The role of the European Qualified Person (QP) extends beyond mere compliance verification.
- Decision-making requires integrating scientific understanding, lifecycle knowledge, and organizational governance.
Purpose of the Study:
- To explore how professional judgment functions in uncertain, fast-paced pharmaceutical manufacturing settings.
- To examine the influence of organizational structures and governance on decision quality.
- To introduce and discuss the concept of patient-relevant decision quality.
Main Methods:
- Literature review and conceptual analysis.
- Exploration of professional judgment within complex systems.
- Discussion of evolving regulatory expectations and technological advancements.
Main Results:
- Specification compliance alone is insufficient for confident decision-making.
- Confidence stems from process understanding, multidisciplinary expertise, and scientific narratives.
- Governance, accountability, and independent judgment are vital for high-quality decisions.
Conclusions:
- Patient-relevant decision quality is a key concept for evaluating pharmaceutical manufacturing decisions.
- Experienced professionals ensure continuity of understanding across product lifecycles.
- The QP is part of a broader system supporting scientifically grounded and ethical outcomes.
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