Medical network on December 16 - in recent years, our country single number set of plasma stations and pulp quantity rapid growth, single plasma stand constantly improve the internal management system, industry regulations continuously strengthened, and guarantee the quality and supply of blood products. In order to further ensure quality of raw material supply and plasma, maintenance for plasma health rights, the implementation of blood products manufacturing enterprise of single plasma stand management main body responsibility, promote the industry self-discipline, improve single plasma standing business capacity, total bureau of national health and family planning commission and the state food and drug supervision and administration issued a "about promote the healthy development of the stations of sole collection of plasma opinion". Specific content is as follows:
A, perfect set planning, set up stations of sole collection of plasma in accordance with the law
(a) set scientific planning. Family planning administrative department of public health at the provincial level shall, in accordance with the regulations on the management of blood products, and the measures for the administration of the stations of sole collection of plasma, science develop program of the establishment of blood stations and single plasma stations within their respective jurisdictions, optimization of single plasma station layout, promote the coordinated development of unpaid blood donation and single plasma work.
(2) strict approval for establishment of new stations of sole collection of plasma. Family planning administrative department of public health at the provincial level to control the "regulations on the administration of blood products", "single plasma stand management method", "about single plasma stand notice matters related to the management of files such as regulation, according to the research and development ability is strong, high plasma comprehensive utilization, single plasma stand management specification of blood products manufacturing enterprises lean principles, in accordance with the law to do a good job of approval for establishment of stations of sole collection of plasma, who adhere to the examination and approval, who, who is in charge. Set the examination and approval, should carefully examine and verify the relevant materials, setting conditions are not met, the firm shall not be approved. Blood products production enterprises when applying for a new set up stations of sole collection of plasma, need to submit the certificate of effective drug production approval of registration materials.
(3) the strict system of the public and for the record. Provincial family planning administrative department of public health in accordance with the "administrative licensing law", the "regulations on the administration of blood products" such as laws and regulations requirements, strictly implement the system of examination and approval of the public, guarantee the legal single plasma station set up the approval process, in accordance with the law to set up single plasma stand for the record.
Health rights and interests, safeguard for plasma participants, ensure raw material quality and safety of blood plasma
(a) maintenance for plasma health rights and interests. All stations of sole collection of plasma to according to the measures for the administration of the stations of sole collection of plasma, the operation rules of stations of sole collection of plasma technology such as rules and regulations requirements, do a good job for plasma health consultation and physical examination, it is forbidden to collect, maternal, menstrual period women and minors sickly and special groups such as plasma. Should strengthen medical physician first aid training, equipped with the necessary first aid equipment and medicine, make emergency rescue preplan and collect on-site observation, after pulp for the for the plasma of pulp adverse reactions, shall be properly disposed of and, when necessary, it shall timely to hospital for treatment. According to regulations of players in a plasma hemoglobin content, serum/plasma protein content, key projects such as serum/plasma electrophoresis test.
(2) to ensure the safety of plasma quality raw materials. All stations of sole collection of plasma to seriously implement the "regulations on the administration of blood products, the measures for the administration of the stations of sole collection of plasma, the stations of sole collection of plasma and the quality control standard and the operation procedures of stations of sole collection of plasma technology, such as documentation requirements, according to the law of the People's Republic of China pharmacopoeia standard requirements, earnestly plasma collection of raw materials, testing, packaging, storage, transportation, records, etc; Continue to strengthen stations of sole collection of plasma laboratory construction and management, perfect the system of quality management files, in accordance with the regulations to carry out the indoor quality control and room between qualitative evaluation; Plasma safety management, and continuously strengthen the raw material strictly abide by the medical waste management regulations and relevant provisions, avoid cross infection. Blood products production enterprise shall, in the stations of sole collection of plasma to carry out the pilot work, nucleic acid detection exploring stations of sole collection of plasma nucleic acid detection work processes, quality management and control system; Gradually expand the scope of the pilot, the end of 2019 to achieve single plasma nucleic acid testing for the whole. Used for screening of blood source of diagnostic reagents shall conform to the relevant provisions of the state.
Third, strengthen corporate responsibility, steadily improving single plasma station service ability
(a) to implement enterprise's main body responsibility. Blood products production enterprise legal representative (head) and single plasma stand the legal representative is the main raw material quality and safety of plasma responsible, be responsible for the raw material supply chain security of plasma. Blood products production enterprises shall strengthen to stations of sole collection of plasma standardization ability construction and quality management, support to stations of sole collection of plasma to strengthen laboratory testing ability and carry out the nucleic acid detection, perfect quality control system, increase financial input, facilities, equipment and talent team construction, improve the single plasma stand for slurry ability. Blood products production enterprise shall formulate and publish to ensure raw material quality, improving the capacity of stations of sole collection of plasma and plasma to the service level of players in a plasma action plan and commitment, and carried out the progress each year. It is forbidden to blood products production enterprises of imported raw materials plasma. Single plasma stations shall be those for plasma as the center, perfect service facilities, enhance service awareness, optimizing the service process, to strengthen science popularization education, physical and mental health care for the plasma, actively build respect, understanding, care for the social atmosphere of plasma, plasma to improve mining slurry ability and materials supply.
(2) to strengthen the construction of single plasma station information. Stations of sole collection of plasma consummating information system construction, strengthen the identification ability for plasma, plasma and supply built before covering raw materials at the end of 2017 the whole process of single plasma station information management system, realize plasma mining raw materials for the whole process of fine management. Family planning administrative department of public health at the provincial level shall be based on a provincial population health information platform, establishing and perfecting the single plasma station information supervision system, the conditional area can be single plasma blood station information supervision system into the area management information system, overall planning, relying on the provincial, city and county level 3 population health information platform, make full use of the information technology means, strengthen the raw material of plasma critical control points for process supervision and management, safeguard the rights and interests of players in a plasma health and raw material quality and safety of blood plasma.
Fourth, strengthen the industry regulations, promote practice in accordance with the law
(a) to do a good job of daily supervision. Local family planning administrative department of public health at all levels must strictly in accordance with the "regulations on the administration of blood products", "single plasma stand management method" and other relevant provisions, in accordance with the law takes office, ready to stations of sole collection of plasma daily supervision and inspection, to stations of sole collection of plasma violation behavior, and punished in accordance with the law; Alleged illegal crime, handed over to the judicial organs in accordance with the law and actively cooperate with the investigation. The food and drug supervision departments at all levels should strengthen the quality of blood products production enterprise supervision, violations of blood products production enterprises on the basis of the pharmaceutical administration law of the People's Republic of China, the "regulations on the administration of blood products" and other relevant laws and regulations.
(2) to establish key inspection system. Where the family planning administrative department of public health at various levels shall, in conjunction with the food and drug regulators at the same level in the area under its jurisdiction stations of sole collection of plasma sorted out basic situation, the existence of blood products production enterprise fails to fulfill its quality management main body responsibility, single plasma internal quality management existence weak link, raw material plasma have quality safe hidden trouble, can not guarantee for the plasma health problems such as single plasma stand, into the list of key supervision, inspection conducted in flight.
(3) the cycle check work earnestly. The family planning administrative department of public health at the provincial level according to the regulations on the administration of blood products, and the measures for the administration of the stations of sole collection of plasma related regulations, according to a single plasma site practice cycle business situation, the technical review and audit supervision and inspection, and so on and so forth. After verification is unqualified, order a rectification within a time limit; After the rectification is not qualified, the cancellation of its single plasma license in accordance with the law. Local family planning administrative department of public health actively cooperate with the food and drug regulator, guide the production enterprises improve the level of research and development of blood products and plasma comprehensive utilization rate of raw materials, and strengthen the set of plasma station investment and management, improve the level of service stations of sole collection of plasma, ascending mining slurry ability, promote the industry self-discipline, benign competition and orderly development.
(4) improve the bad credit registries. Place the food and drug supervision departments at all levels should strengthen the quality of blood products production enterprise supervision, blood products production enterprise exists violation behavior, should be incorporated into bad blood products production enterprise credit registries. Where the family planning administrative department of public health at all levels should strengthen the quality supervision stations of sole collection of plasma, to stations of sole collection of plasma violation behavior, into the stations of sole collection of plasma and blood products production enterprise bad credit registries. Local family planning administrative department of public health and food and drug supervision departments at all levels shall regularly announce the blood products production enterprise and the plasma stand bad credit registries.
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A, single plasma stand management information
Raw material plasma is dedicated to stations of sole collection of plasma acquisition blood plasma products production raw material, direct relationship between the blood products quality safety and the health rights and interests of the people. For many years, the state health and family planning commission and food and drug supervision administration attaches great importance to the quality of the raw material plasma and blood products security and supply, improve the production and supply of blood products and plasma station management system of laws and regulations, strengthen supervision and management, obtaining good results. In the end of 2015 there are 201 single plasma stand, 28 blood products manufacturers to provide raw materials respectively plasma. "Twelfth five-year" period, the national material plasma from 3800 tons in 2011 growth in 2015 to nearly 6000 tons, the production of human blood albumin, static note immunoglobulin, human clotting factor Ⅷ, human prothrombin complex all have substantial growth, ease the contradiction between supply and demand of clinical blood products gradually.
Second, the drafting process
Stations of sole collection of plasma was collected and production enterprises with raw materials of plasma units of blood products, set up by blood products manufacturing enterprises. At present, the low degree of industrial concentration, blood products industry small production scale, technology research and development ability weak, the production efficiency is low, some blood products production enterprises to stations of sole collection of plasma inadequate investment and management does not reach the designated position, single plasma stand by for slurry ability remains to be further promoted, consciousness of individual stations of sole collection of plasma in accordance with the law practice and further strengthen internal management, the national health and family planning commission, food and drug supervision administration of thorough investigation and study, problem oriented, a special meeting, widely discussed, the existing single plasma stand management on the basis of the relevant laws and regulations, to form the "about promoting the healthy development of the stations of sole collection of plasma opinions" (hereinafter referred to as "opinions").
Third, the main content
"Opinion" around the security key link in the process of plasma quality and raw material supply, further defined the blood products production enterprises must implement to stations of sole collection of plasma management main body responsibility, promote the healthy development of the stations of sole collection of plasma, meet the demand of domestic clinical medical treatment of blood products, blood products in our country enterprise core competitiveness, boost the health of China construction.
(a) set the planning, set up stations of sole collection of plasma in accordance with the law. Is a program of the establishment of science to develop and optimize the single plasma station layout, work as a whole the unpaid blood donation and single plasma coordinated development. The second is strict approval for establishment of new stations of sole collection of plasma. New stations of sole collection of plasma to follow to the research and development ability is strong, high plasma comprehensive utilization, single plasma stand management specification the principle of the blood products production enterprise tilt, who insisted on examination and approval, who, who is in charge. Three is a strict system of the public and for the record.
(2) security for plasma health rights and interests, ensure raw material quality and safety of blood plasma. Is a maintenance for plasma health rights and interests, demand in accordance with the law in accordance with the rules for plasma health consultation, physical examination and health care, etc. 2 it is to ensure the safety of plasma quality raw material, the requirement to strengthen laboratory construction and management, to ensure the safety of raw material quality of plasma. Three is the requirement of blood products production enterprise in accordance with the law to carry out the nucleic acid test pilot work, realizing a complete coverage of the nucleic acid detection by 2019.
(3) strengthen the enterprise responsibility, steadily improving single plasma station service ability. One is to carry out the enterprise's main body responsibility, improve the single plasma stand for slurry ability, improving mining slurry ability and plasma supply of raw materials. The second is to strengthen the construction of single plasma station information. Requirements set up covering the whole process of plasma and supply raw materials single plasma station information management system, using information technology means to strengthen the supervision and management of the mining process for pulp.
(4) strengthen the industry regulation, promote practice in accordance with the law. One is to do a good job of daily supervision, required local family planning administrative department of public health and food and drug supervision departments at all levels in accordance with the law. The second is to establish key inspection system. Asked local family planning administrative department of health under the state council in conjunction with the food and drug regulators to stations of sole collection of plasma basic situation within their respective jurisdictions build a list of key supervision slurry station, combined to carry out the flight check. Three is to require the provincial family planning administrative department of public health check work earnestly cycle. Four is sound bad credit registries to blood products manufacturing enterprises and stations of sole collection of plasma violation behavior in bad credit registries. |
