《药品管理法》及其《实施办法》用专门条款,对医疗单位药品和制剂的管理作了规定与要求。对医疗单位药检部门的职能、责任设施等都有具体要求。本文结合《药品管理法》、《实施办法》及医院制剂室《制剂许可证》验收标准(1989),就医疗单位药检部门如何保证药品质量进行探讨。 一、《药品管理法》等法规对医疗单位药检部门的要求 The “Drug Administration Law” and its “Implementation Measures” make special provisions on the administration of medicines and preparations in medical units. The medical unit’s drug inspection department functions, responsibilities and facilities have specific requirements. This article combines the “Drug Administration Law”, “Implementation Measures” and the hospital preparation room “preparation permit” acceptance criteria (1989), medical units how to ensure drug quality inspection department to explore. First, the “Drug Administration Law” and other laws and regulations of the medical unit drug inspection department requirements