Biological products are different from general medical drugs. They play a role by stimulating the immune system and producing immune substances (such as antibodies), and humoral immunity, cellular immunity or cell-mediated immunity appear in human body.
Biological products include preventive biological products, therapeutic biological products and diagnostic biological products. Commonly used in clinic are: human albumin, human immunoglobulin, influenza virus split vaccine, transfer factor and so on!
Three principles of transportation:
① Adopt the fastest mode of transportation to shorten the transportation time;
② Cold chain method is generally used for transportation;
③ During transportation, attention should be paid to prevent products from freezing.
Extended data:
Warehousing acceptance: China implements batch issuance management for vaccine products, blood products, in vitro biological diagnostic reagents for blood source screening and other biological products specified by China Food and Drug Administration, and each batch of products is subject to compulsory inspection and audit when it is listed or imported.
Those who fail to pass the inspection or are not approved by the audit shall not be listed or imported. Therefore, the supplier should provide the batch issuance report when receiving the goods.
Use management: The preparation of biological products must be based on the prescription or doctor's advice issued by the doctor, and can only be prepared, reviewed, distributed or configured after the pharmacist has passed the examination. Close observation of adverse drug reactions during use.
administrative laws and regulations
(a) the basic production conditions of biological products production units should meet the requirements of microbial operation in the laboratory; Should have sterilization operation conditions; There are cold storage facilities; Should be able to self-check products; Production shall be presided over by the competent technician or above to achieve civilized production; The products shall conform to the regulations on the administration of biological products formulated by the administrative department of health of the State Council. ?
(II) Authority and Scope of Management Biological products: The Ministry of Health shall manage them in a unified way, and the Institute of Biological Products directly under the Ministry shall produce them. Other products with special needs can only be produced after being reported to the Ministry of Health for approval by the provincial health administrative department.
Blood products: In addition to the Institute of Biological Products under the Ministry of Health, all provinces, autonomous regions and municipalities directly under the Central Government can also produce blood products, but there can only be 1 ~ 2 production sites, and the provincial drug inspection institute will supervise and inspect the product quality.
Other medical and health units shall not produce biological products and blood products. Individual scientific research needs, the production unit can not normally supply varieties, must meet certain conditions, with the consent of the provincial health administrative department to develop, and the approval of the verification agency, reported to the provincial health administrative department for examination and approval, before human trials can be carried out in a certain range, but no trial production can be carried out.
(III) Issuance of Business License The biological products produced by the Institute of Biological Products of the Ministry of Health have been approved by the administrative department of health of the State Council and the State Administration for Industry and Commerce. Provincial biological products production units shall be examined and approved by the provincial health administrative department in conjunction with the provincial administration for industry and commerce before issuing business licenses.
(4) The quality standard shall be tested according to the quality standard stipulated in the Regulation of Biological Products issued by the Ministry of Health 1979.
(5) The production, sale and storage of biological products of the units under the Ministry of Health shall be uniformly balanced by the Ministry of Health. The production and sales of blood preparations in provincial blood stations are arranged by the Provincial Health Department.
(6) Imported biological products shall be inspected by the Inspection Institute of the Ministry of Health. Blood products are inspected by the port drug control office. Blood is thicker than water in China, and AIDS has spread abroad. We must strictly control the import of blood products.
(7) The formulation and adjustment of prices shall be managed by the Ministry of Health. When a new product is tried out or customized according to similar products, it should be reported to the Ministry of Health for the record, and then reported to the Ministry of Health for approval after it is put into production.
(eight) the management of biological products purchased by hospitals should be strictly in accordance with the requirements of reserve conditions, pre-stored, and used according to the validity period. Strict indications to prevent abuse. Strengthen the monitoring of blood products to prevent the use of blood products to spread diseases.
References:
Baidu encyclopedia-biological products