| Popis: |
Good Manufacturing Practice (GMP) and the need for product improvement became a major issue in blood transfusion in many western countries in the late 60s. This was most evident in the United States where a centralized agency, the Food and Drug Administration (FDA), was empowered to control not only the manufacturers of drugs but also blood banks and the manufacturers of products originating from human blood and its components. Today, most countries have created such agencies which control (more or less intensively) the activities of blood banks and fractionation facilities. This appears to be related to several factors: 1. An ever increasing number of safety tests that have to be performed, implying that the possibility of errors also increases. 2. The increasing complexity of technology and equipment 3. A shortage of appropriately trained laboratory personnel in some countries. 4. The development of new products for diseases for which no, or only limited, treatments exist. |
