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随着《中华人民共和国药品法》的颁布与实施,我国的医院制剂基本走上了法制化轨道。《制剂许可证》的换发与检收制度,对医院的制剂条件、人员素质、制剂工艺以及制剂质量都起到了促进作用,医院制剂室的“软硬件”建设都有了显著的改善,制剂质量有了明显的提高,确保了临床用药的安全有效。但是,医院制剂的质量控制、生产条件以及生产规模等方面,与药厂相比较还存在着许多不足。随着制剂工业的迅速发展,临床治疗所
With the promulgation and implementation of the “Drug Law of the People’s Republic of China”, the hospital preparations in our country have basically taken the legal track. The system of renewal and collection of “preparation license” has played a catalytic role in the preparation conditions, the quality of personnel, the preparation technology and the preparation quality of the hospital, and the construction of “software and hardware” in the hospital preparation room has been significantly improved. The quality has been significantly improved to ensure the safe and effective clinical medication. However, the quality control of hospital preparations, production conditions and scale of production, compared with the pharmaceutical companies there are still many deficiencies. With the rapid development of preparation industry, clinical treatment