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Measuring What Matters: A North-Star KPI Set for CMC-Intensive Programs

Author(s) Pawankumar Suresh
Country India
Abstract The complexity of Chemistry, Manufacturing, and Controls (CMC)-intensive programs requires performance metrics to be streamlined and focused on outcomes, since current approaches in industry typically use long and broken KPI frameworks that generally overwhelm users with irrelevant data, which generally add nothing to the decision-making process. This study proposes a minimal, outcome-linked KPI framework, which uses three types of indicators, the Right-First-Time (RFT) rate, Corrective and Preventive Action (CAPA) cycle time, and release lead time, as the “North-Star” for a KPI framework. This paper draws from details from case studies and literature from delivery of manufactured pharmaceuticals, healthcare services operations, digital transformation, and sophisticated communication system approaches to demonstrate the multi-modality approach to formulating a KPI framework. The results presented indicate by explicitly linking KPIs to quality outcomes and relating to regulation compliance to drive improvement may also positively impact managing operational complexity, product lifecycle management, reducing risk, and increasing stakeholder trust. This research proposes, among other ideas, the need for a standardized cross-modality KPI approach that is both simple and robust, for CMC teams and regulators to create meaningful, comparable, and scalable performance insights.
Keywords CMC programs, Key Performance Indicators (KPIs), Right-First-Time (RFT), CAPA cycle time, release lead time, regulatory compliance, performance measurement, pharmaceutical manufacturing, outcome-linked metrics, lifecycle management
Field Medical / Pharmacy
Published In Volume 3, Issue 12, December 2022
Published On 2022-12-12
Cite This Measuring What Matters: A North-Star KPI Set for CMC-Intensive Programs - Pawankumar Suresh - IJLRP Volume 3, Issue 12, December 2022. DOI 10.5281/zenodo.17205229
DOI https://doi.org/10.5281/zenodo.17205229
Short DOI https://doi.org/g943nj
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