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目的:通过品管圈活动,分析医院制剂质量管理体系的建立及其原因,从而提升制剂生产的管理能力,提高制剂质量。方法:遵循PDCA循环,按照品管圈活动的十大步骤改进制剂质量,评价有形成果和无形成果。结果:抽检和分析制剂生产的原辅料、中间体和清场情况,以及供应商考核和制剂投诉情况等原因,采用改进生产设备、细化岗位职责、加大培训力度和考核以及优化生产流程的措施,健全制剂质量管理体系,制剂质量有了明显提高。结论:持续改进品管圈活动内容,有效提高医院制剂的生产效率,优化生产工艺和流程,推动医院制剂生产质量持续改进。
Objective: To analyze the establishment of quality management system of hospital preparation and its reasons through quality control circle activities so as to enhance the management ability of preparation production and improve the quality of preparation. Methods: Following the PDCA cycle, the quality of preparation was improved according to the ten steps of QA activities and tangible and intangible outcomes were evaluated. Results: Sampling and analysis of the raw materials, intermediates and clearances, as well as supplier assessment and preparation complaints, etc., Adopting measures to improve production equipment, refine job responsibilities, intensify training and examination, and optimize production process , Improve the preparation quality management system, preparation quality has been significantly improved. CONCLUSION: The continuous improvement of QA activities will effectively improve the production efficiency of hospital preparations, optimize the production processes and processes, and promote the continuous improvement of hospital preparation production quality.