Quality and safety
Overview
- Provision of blood products and their clinical use is a multi-step process with risk of error in each process. Particular safety considerations arise from the biological nature of the starting materials used, the manufacturing process involved, and the test methods needed to characterize the production consistency.
- An effective quality system in the blood establishment provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. Quality systems are the key to ensuring the availability of safe blood for all patients needing transfusions.
- Harmonization on quality assurance and safety of blood products calls for a quality assurance system based on the existence of a national structure that is independent of the manufacturer and that is responsible for granting licenses for blood products, defining procedures for products release and for post-marketing surveillance systems.
- GMP is a system for ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the product specification. The implementation and enforcement of Good Manufacturing Practices (GMP) in Blood and Plasma Collection Establishments is a prerequisite for consistent quality in the preparation of blood and blood products, and a priority to minimize the risk of transmitting currently known and emerging blood-borne diseases.
- It is a WHO priority to contribute to the advancement of technical expertise of National Regulatory Authorities and the formation of regulatory regional networks so that only blood products of assured quality and safety are used worldwide.
