Model quality assurance system for procurement agencies.

The document focuses on the World Health Organization’s (WHO) Model Quality Assurance System (MQAS) for procurement agencies, providing a comprehensive framework to ensure the quality, safety, efficacy, and performance of health products procured or supplied globally. Originally adopted in 2005 and...

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Detalles Bibliográficos
Publicado en:WHO Drug Information Vol. 40; no. 2; pp. 307 - 387
Formato: glossary tables/charts Journal Article
Publicado: World Health Organization 2026
Acceso en línea:Ver este registro en EBSCOhost
Descripción
Sumario:The document focuses on the World Health Organization’s (WHO) Model Quality Assurance System (MQAS) for procurement agencies, providing a comprehensive framework to ensure the quality, safety, efficacy, and performance of health products procured or supplied globally. Originally adopted in 2005 and revised most recently in 2026, MQAS guides procurement agencies—including international, national, non-governmental, and donor organizations—in applying harmonized, risk-based quality assurance practices across pharmaceuticals, biologicals (including vaccines), medical devices (including in vitro diagnostics), blood products, and vector control products. Key components include qualification of products and suppliers based on reliance on trusted regulatory authorities (such as WHO-Listed Authorities and the WHO Prequalification Programme), quality management systems, purchasing procedures, receipt and storage, distribution, and product quality surveillance. The system emphasizes clear separation of procurement and regulatory functions, transparency, accountability, and continuous monitoring to maintain product integrity throughout the supply chain, while aligning with international standards and national legislation.