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Production of bovine serum
(1) The manufacturer of bovine serum should be an independent legal entity registered at the industrial and commercial department, and possess the production shop and equipment appropriate for the large-scale production of bovine serum.
(2) The production manager and the staff of the manufacturer should have professional knowledge, and have received training and passed the quality examination before taking their positions.
(3) There should be stable source of bovine source materials. A legal agreement should be signed with the bovine supplier, the content of which should include detailed information about the immunization status of the herd of cattle and epidemic monitoring. The bovine materials from epidemic area of infectious diseases (such as foot and mouth disease, tuberculosis, bovine brucellosis, mad cow disease, etc.) should not be used.
(4) The water and other materials used for production should meet the requirements of Chinese Pharmacopoeia, Chinese Quality Control Standard for the Main Raw and Auxiliary Materials for Biological Product Production and other relevant standards.
(5) Stable batch production techniques should be used, and at least one step of 0.1 ¦Ìm filtration is included in the technical process. The filling process should be carried out in hundred-grade cleaning region.
(6) Sterilization and pyrogen-eliminating treatment should be performed on the appliance in direct contact of serum.
(7) Systemic production quality management system should be established, including batch production record and the operational regulations for production process.
(8) Non-bovine source serum materials should not be used for production, and preservatives or antibiotics should not be added into the product.
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