关键词: 医疗机构制剂室, 现场检查, 缺陷, 质量保证, 质量控制

Abstract:

Objective： to provide countermeasures and suggestions for the development of preparation rooms of medical institutions in Qinghai province， and further standardize the production behavior of preparation rooms of medical institutions.Methods： Through the administrative licensing inspection and routine inspection of preparation rooms in medical institutions in recent years， the defects in quality assurance and quality control found in the on-site inspection of preparation rooms in 32 medical institutions were statistically analyzed.Results： There are some problems in personnel and institutions， building and facilities， equipment and materials to varying degrees， in the preparation rooms of medical institutions， and the management of medicinal preparations in medical institutions needs to be further standardized.Conclusion： It is suggested that the relevant government departments should increase policy support for the preparation rooms of medical institutions， promote the development of the preparation rooms of medical institutions， and at the same time， make use of the superior resources of hospital preparations to guide the preparation rooms to be centralized， set up regional preparation centers， and take the road of centralized and characteristic development. It is suggested that the preparation rooms of medical institutions should strengthen team building， personnel training and production process management， and further improve the management level of "people， machines， materials， methods and environment" to ensure the safety and controllability of preparation quality.

Key words: Preparation room of medical institutions； , On-site inspection； , Defects； , Quality assurance； , Quality control