ASSESSMENT OF DONOR ACCEPTANCE, APHERESIS PLATELET COLLECTION, SCREENING TESTING, AND QUALITY CONTROL OF APHERESIS PLATELET CONCENTRATES ACCORDING TO GMP-WHO STANDARDS AT THE NATIONAL INSTITUTE OF HEMATOLOGY AND BLOOD TRANSFUSION, 2025
Main Article Content
Abstract
Objective: To assess donor acceptance, apheresis platelet collection, screening testing, and quality control of apheresis platelet concentrates (APCs) according to GMP-WHO standards at the National Institute of Hematology and Blood Transfusion in 2025.
Subjects and methods: A cross-sectional study was conducted from May to December 2025 at the National Institute of Hematology and Blood Transfusion. An assessment tool based on GMP-WHO guidelines, Appendix II of Circular No. 28/2025/TT-BYT, and current regulations comprised 420 criteria across 12 domains. Of these, 124 criteria directly related to the study objectives: donor acceptance and apheresis platelet collection (69), screening testing (43), and quality control (12). The quality of 250-mL APCs was assessed for volume, platelet count, platelet concentration, and residual white blood cell count according to Circular No. 26/2013/TT-BYT.
Results: The overall percentage across 420 criteria was 81,7%. The three domains achieved 87,0% for donor acceptance and apheresis platelet collection, 98,8% for screening testing, and 58,3% for quality control. The quality control sampling plan had the lowest score (20,0%). Among 2.147 units of 250-mL APCs assessed, 100% met the requirements for volume and platelet concentration; residual white blood cell and platelet counts met requirements in 99,5–100% and 94,7–97,1% of units, respectively, depending on the apheresis system.
Conclusion: Donor acceptance, apheresis platelet collection, and screening testing activities demonstrated a high level of compliance with GMP-WHO standards, whereas quality control activities remained limited. The quality parameters of the final products generally met the requirements of the Ministry of Health. However, quality control sampling plans, trend analysis, validation, and continuous improvement should be further strengthened to improve the effectiveness of the quality management system for APC production
Keywords
GMP-WHO, apheresis platelet concentrates, donor acceptance, plateletpheresis collection, screening testing, quality control, blood transfusion
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References
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