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输液是通过静脉直接进入人体的大剂量注射液。由于它直接进入人体静脉,用量又大,因此,对它的质量应严格要求。要保证输液的质量,仅靠质量检查是不够的,因为质量检查采取的抽样方法,受抽样概率和检查方法的影响,检查的结果并不能真实反映出每一瓶输液的质量。要提高输液的质量,就必须进行全程生产质量控制,以减少注射液生产过程中的污染。 生产环境的质量控制。 根据我国《药品生产质量管理规范》规定,生产输液必须
Infusion is through the vein directly into the body of large doses of injection. Because it directly into the human vein, the amount of large, therefore, its quality should be strictly required. To ensure the quality of infusion, quality inspection alone is not enough, because the quality of sampling methods taken by the sampling probability and inspection methods, the results of the inspection does not truly reflect the quality of each bottle of infusion. To improve the quality of infusion, it is necessary to carry out the entire production quality control to reduce the pollution in the injection production process. Production environment quality control. According to China’s “drug production quality management practices” provisions, the production of infusion must