在日本的仿制药行业创建质量文化发展的评估指标
Shiho Takahashi1, Tetsuhito Takarada2, Riho Kitamura2
1Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan 3b21705@ed.tus.ac.jp.
PDA journal of pharmaceutical science and technology
|October 17, 2023
概括
一个新的指数有助于日本仿制药公司评估和改善其质量文化. 该工具可视化了开发水平,有助于持续监测和提高制药制造标准.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 质量管理系统 质量管理系统
- 公司文化 企业文化
背景情况:
- 日本的非法制药业强调了需要强有力的质量控制.
- 质量文化的不充分发展是导致制造不合规的一个关键因素.
- 现有的评估工具无法充分体现日本制药公司的质量文化发展.
研究的目的:
- 建立一个新的评估指数,以可视化日本仿制药公司的质量文化发展程度.
- 提供一种工具,用于不断监测和改善这些公司内部的质量文化.
- 为了解决日本制药环境中缺乏评估质量文化的特定指数.
主要方法:
- 对日本仿制药协会成员进行了问卷调查.
- 该调查包括五个类别的28个问题:员工成长/满意度,管理层承诺,改进活动,沟通和环境/健康/安全.
- 从37个营销授权持有者 (MAH) 和61个制造工厂的294名个人收集了回复,按管理层,管理层和非管理层角色分类.
主要成果:
- 该研究证实,虽然企业哲学得到了认可,但对质量文化的认识因员工角色而异.
- 一个值得注意的发现是对员工和设施的资源分配不足.
- 开发的指数有效地使相对比较和可视化需要提高质量文化的领域.
结论:
- 成功建立并可视化了评估国内仿制药制造商质量文化发展的指数.
- 该指数是公司评估和增强其质量文化的宝贵工具.
- 这些发现强调了量身定制的资源分配和角色特定沟通在培养强大的质量文化方面的重要性.
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