PRACTICAL EXPERIENCE IN BUILDING A QUALITY CULTURE TO SUSTAIN GOOD MANUFACTURING PRACTICES (GMP) AT THE BLOOD BANK – BLOOD TRANSFUSION HEMATOLOGY HOSPITAL, 2019–2026
Main Article Content
Abstract
Objective: To describe practical experience in building a quality culture to sustain Good Manufacturing Practices (GMP) at the Blood Bank of the Blood Transfusion Hematology Hospital during the period 2019–2026.
Results: Following the attainment of GMP certification for plasma production in 2019, the unit progressively shifted its focus from meeting external assessment requirements to sustaining a robust and effective quality management system. A quality culture was fostered through strong commitment from senior management, strengthening of the quality management system, continuous training, non-punitive deviation reporting, quality risk management, change control, and validation activities. These efforts contributed to improved compliance, enhanced traceability, proactive prevention of deviations, and the promotion of continuous improvement.
Conclusion: Developing a quality culture is a critical prerequisite for the sustainable implementation of GMP in blood establishments. It contributes to ensuring the quality, safety, and availability of blood and blood components for clinical use.
Keywords
Quality culture, GMP, blood bank, quality management, continuous improvement
Article Details
References
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