医疗机构制剂室作为制剂配制的场所，是药品供应体系的重要补充。药品监管部门依法对医疗机构制剂进行监管，并开展日常监督检查。2022—2024年贵州省医疗机构制剂室日常监督检查发现的缺陷主要集中在机构与人员、文件、质量管理与自检、设备、物料、配制管理方面。归纳分析了贵州省医疗机构制剂室监督检查发现的缺陷，提出改进建议，以期为提升医疗机构制剂质量管理水平和监管工作提供参考。

The preparation room of medical institutions, as a place for preparing preparations, is an important supplement to the drug supply system. The drug regulatory authority supervises the preparations of medical institutions in accordance with the law and conducts daily supervision and inspection. The defects discovered during the daily supervision and inspection of the preparation rooms of medical institutions in Guizhou Province from 2022 to 2024 mainly focus on the aspects of institutions and personnel, documents, quality management and self-inspection, equipment, materials, and preparation management. This article summarizes and analyzes the defects found in the supervision and inspection of the preparation room of medical institutions in Guizhou Province, and proposes improvement suggestions, in order to provide reference for improving the quality management level and regulatory work of medical institutions’ preparations.

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