Good practices for blood establishments
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World Health Organization
Abstract
Description
xiii, 80 p.
This WHO guidance document sets out good practices for blood establishments to ensure the quality, safety and efficacy of blood and blood components for transfusion, as well as plasma intended for further industrial fractionation. It reflects current good manufacturing practice (GMP) principles and aligns with international standards to support harmonization across regulatory systems. The publication addresses the entire transfusion chain, including collection, testing, processing, storage, release and distribution, emphasizing the need for comprehensive quality systems and risk management approaches to protect donors and recipients and ensure product traceability. Structured into key operational domains—such as quality management, personnel, premises, equipment, documentation and outsourced activities—the document provides technical guidance for blood establishment managers, staff and national regulatory authorities. It highlights the importance of validated processes, standardized procedures, and continuous quality improvement, while also addressing developments in screening technologies, automation and plasma utilization. The guidance is intended to support the implementation of efficient, well-regulated blood services and may serve as a basis for inspection and national regulatory requirements, contributing to global efforts to improve access to safe and quality-assured blood products.
This WHO guidance document sets out good practices for blood establishments to ensure the quality, safety and efficacy of blood and blood components for transfusion, as well as plasma intended for further industrial fractionation. It reflects current good manufacturing practice (GMP) principles and aligns with international standards to support harmonization across regulatory systems. The publication addresses the entire transfusion chain, including collection, testing, processing, storage, release and distribution, emphasizing the need for comprehensive quality systems and risk management approaches to protect donors and recipients and ensure product traceability. Structured into key operational domains—such as quality management, personnel, premises, equipment, documentation and outsourced activities—the document provides technical guidance for blood establishment managers, staff and national regulatory authorities. It highlights the importance of validated processes, standardized procedures, and continuous quality improvement, while also addressing developments in screening technologies, automation and plasma utilization. The guidance is intended to support the implementation of efficient, well-regulated blood services and may serve as a basis for inspection and national regulatory requirements, contributing to global efforts to improve access to safe and quality-assured blood products.
Keywords
Blood Transfusion, Blood Banks, Blood Donors, Plasma, Blood Preservation, Blood Safety, Safety Management, Quality Assurance, Health Care, Quality Improvement, Equipment and Supplies, Laboratories, Serologic Tests, Microbiological Techniques, Documentation, Contracts, Guideline, standards, methods, supply and distribution