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Redefining quality in cell and gene therapies: Lessons from implementing electronic QMS in academic cGMP facility
Xia Wu1, Amaia Cadinanos-Garai1, Vivian Quach1
1USC/CHLA Cell Therapy Program, University of Southern California and Children's Hospital of Los Angeles, Los Angeles, CA 90033, USA.
Summary
Implementing electronic quality management systems (eQMS) streamlines cell and gene therapy (CGT) manufacturing in academic facilities. This transition enhances efficiency and regulatory compliance, overcoming resource limitations.
Area of Science:
- Biotechnology
- Pharmaceutical Manufacturing
- Quality Management Systems
Background:
- Cell and gene therapies (CGTs) manufacturing requires stringent quality management, particularly in resource-limited academic current Good Manufacturing Practice (cGMP) settings.
- Traditional paper-based quality management systems (QMSs) present challenges including errors, poor traceability, and compliance risks.
Purpose of the Study:
- To evaluate the benefits of adopting an electronic QMS (eQMS) in an academic cGMP facility.
- To provide practical insights and guidance for implementing eQMS in similar institutions.
Main Methods:
- An in-depth case study analysis of an academic cGMP facility (University of Southern California and Children's Hospital of Los Angeles).
- Review of practical implementation strategies, including platform selection, phased rollout, and staff training.
Main Results:
- Adoption of an eQMS led to tangible improvements in operational efficiency and regulatory readiness.
- Identified common implementation challenges and proposed practical solutions.
Conclusions:
- eQMS adoption is a viable strategy for academic CGT manufacturers to enhance efficiency and compliance.
- Lessons learned offer valuable guidance for other institutions navigating eQMS implementation.
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