Christie R B
Armour Pharmaceutical Company, Eastbourne, East Sussex, UK.
Blood Coagul Fibrinolysis. 1994 Dec;5 Suppl 4:S39-41. doi: 10.1097/00001721-199412004-00012.
Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.
血液制品制造商必须维持尽可能高的血浆筛查标准和良好生产规范,以确保最高纯度和病毒安全性。私营企业在执行和遵守国家及国际法规方面经验丰富。这些要求在以下方面涉及相当高的成本:(1)血浆采集设施,(2)研究与临床研究,(3)生产,以及(4)质量控制。完全自给自足将意味着失去许多现有资源。一种替代方案是公私部门之间开展合作,以满足所有需要血浆衍生产品的患者的需求。目前自给自足的定义表明其在财务上不可行。