About solid plasma stations management matters related to notice

Health ministry of China www.moh.gov.cn the 2012-01-20 17:00:52

Health medical ZhengFa [2012] no. 5

        All provinces, autonomous regions, municipalities directly under the central government health TingJu, food and drug administration (and drug administration), xinjiang production and construction corps health bureau, food and drug administration:

        In 2008, the solid plasma stations to manage the way "(hereinafter referred to as the measures") and formal, "method" perfected the stations of plasma stations set planning, regulate the stations of plasma stations quality management, guarantee the rights and interests of the person for the plasma, to promote the plasma stations stations scientific development which has played a positive role. In recent years, the provincial health administrative departments in implementing the "way" process, also puts forward some problems and Suggestions. To ensure the smooth implementation of the methods, and promote the healthy development of work in pulp and will now solid plasma stations management matters related to notice the following:

        A, "method" article 11 related content explanation

        Blood products manufacturing enterprises apply for the establishment of a new solid plasma stations, the registration of the blood products shall be no less than six varieties (undertaking state plan of the blood products immune task production enterprise of not less than five varieties), and also contain human albumin, people's immune globulin and people blood coagulation for a subclass products. Sure the blood products production enterprise registered blood products when the species, the same kind of different specifications of the preparation and composition of blood products should press a variety calculation.

        Second, stations of the plasma stations set for examination and approval

        Encourage all stations approval for establishment of plasma stations, and appropriate to expand existing stations in plasma stations pulp area, improve stations plasma collection capacity. Especially in the eastern region, shall support to meet the conditions of the blood products production enterprise set solid plasma stations and for the "1025" period, realize stations within its jurisdiction by volume and plasma slurry blood products to achieve the goal of demand for basic balance. Everywhere in setting the examination and approval stations plasma stations, to research and development ability, comprehensive utilization of plasma high blood products production enterprise tilt, guide the blood products production enterprises to improve the development level and plasma comprehensive utilization ratio.

        Three, blood products production enterprise ability construction

        The blood products production enterprise, to perfect quality management system, further increased research investment, improving production technology, increase the finished product output, improve the comprehensive utilization of plasma, and strengthen the subordinate stations of plasma stations capacity building and quality management, strengthen the laboratory testing ability, well for the plasma service work, improve mining pulp ability, ensure the quality and safety of plasma stations.

○ 2 January 10, 12