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序列化对爱尔兰制药网站运营效率和生产力的影响
Daniel O' Mahony1, Alan Lynch2, Olivia McDermott3
1College of Science and Engineering, University of Galway, Galway, Ireland.
Therapeutic innovation & regulatory science
|May 29, 2024
概括
药品序列化技术是药品供应链安全的强制要求,对运营效率产生了负面影响,并增加了爱尔兰制造商的成本. 资本支出明显高于预期,影响了整体生产率.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 供应链安全 供应链安全
- 监管合规性符合性 监管合规性
背景情况:
- 药物序列化技术的实施旨在提高药品供应链的安全性,防止假冒药品.
- 这一监管要求需要药品制造商进行大量的金融投资.
研究的目的:
- 调查药物序列化对爱尔兰制药生产场所运营效率和生产率的影响.
- 量化与实施序列化相关的财务影响和运营挑战.
主要方法:
- 在爱尔兰的11个制造工厂进行了定性研究.
- 该研究涉及114条自动化包装线,约占全国容量的65%.
主要成果:
- 序列化对整体设备效率 (OEE),线路可用性和包装制药的单位成本产生了负面影响.
- 序列化估计的资本成本是监管机构预测的四倍,平均成本为每包4.1美分.
- 大批量的网站每年产生高达450万欧元的序列化成本,使销售商品的平均成本增加了2.7%.
结论:
- 制药制造商正在转向更大批量生产,以减轻与序列化相关的效率损失.
- 建议使用序列式折旧系数来准确评估其对销售商品成本的影响.
- 这项研究提供了首次以制造商为中心的对序列化成本及其对生产率和运营效率的影响分析.
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