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目的对比研究近14年军队药品制剂质量监督抽验情况,分析评价监督管理制度对药品制剂质量提升的影响。方法搜集汇总2003—2016年军队药品制剂质量监督抽验工作相关文件和军队药品制剂质量抽验资料,回顾性分析抽验单位、批次、抽验合格率等数据,从经费保障、评价考评、工作模式、能力建设、承担国家任务以及工作成效等方面,评价军队药品制剂抽验工作近14年发展情况。结果军队药品制剂质量基本保持稳定提升,其中中药材及饮片、医疗机构制剂不合格率较高;军队药品制剂质量监督抽验覆盖面增加。结论制剂质量管理规范、制剂标准提升、药检所数据会审等监管政策提高了执法效率,对抽验结果和实验室管理发挥积极作用,有效保障了广大官兵、老干部和人民群众用药安全。
Objective To comparatively study the quality supervision and sampling of military pharmaceutical preparations in the past 14 years and analyze the influence of supervision and management system on the quality improvement of pharmaceutical preparations. Methods To collect and summarize the relevant documents of quality supervision and inspection of military pharmaceutical preparations and the sampling quality of military pharmaceutical preparations from 2003 to 2016, and to retrospectively analyze the data of sampling units, batches and passing rate of sampling, from the aspects of funding guarantee, appraisal and evaluation, working mode and ability Construction, commitment to national tasks and the effectiveness of work, evaluation of the development of military pharmaceutical preparations for nearly 14 years of development. Results The quality of the military pharmaceutical preparations remained basically stable. The unqualified rate of preparation preparations for Chinese medicinal herbs, herbal pieces and medical institutions was relatively high. The coverage of quality supervision and inspection of military pharmaceutical preparations increased. Conclusion The regulatory policies of preparation quality management standard, preparation standard improvement and data review of drug inspection institute improve the efficiency of law enforcement, play an active role in the test results and laboratory management, and effectively ensure the safety of the general officers and soldiers, veteran cadres and people.