测试设施管理:新时代的责任和范式
M Breda1, M Pilla1, M Brazzarola1
1Test Facility Management, Aptuit (Verona) Srl, an Evotec company, Via A. Fleming, 4, Verona, Italy.
Journal of pharmacological and toxicological methods
|April 18, 2024
概括
有效的良好实验室实践 (GLP) 测试设施管理 (TFM) 对于监管数据的接受至关重要. 随着科学环境的不断变化,TFM在未来的运作中需要进行重大调整.
科学领域:
- 监管科学 监管科学
- 实验室管理 实验室管理
- 质量保证 质量保证 质量保证
背景情况:
- 良好的实验室实践 (GLP) 规定对于监管机构接受研究数据至关重要.
- 测试设施管理 (TFM) 监督符合GLP的设施内的运行.
- 自GLP的早期以来,TFM操作的复杂性显著增加.
研究的目的:
- 突出测试设施管理 (TFM) 在维护GLP合规方面发挥的关键作用.
- 强调需要根据快速的科学和技术进步,调整TFM战略.
- 确定是否需要对TFM角色的绩效和责任进行重大演变.
主要方法:
- 分析GLP原则及其对测试设施运行的影响.
- 审查不断变化的科学和技术环境,影响实验室研究.
- 评估测试设施管理 (TFM) 的现有框架和责任.
主要成果:
- 对于监管数据的接受,符合GLP是不可谈判的.
- TFM 的运营环境变得越来越复杂.
- 快速的科技创新需要对TFM实践进行重新评估.
结论:
- 传统的TFM角色需要大量的调整,以满足当前和未来的需求.
- 积极主动地对待TFM至关重要,以确保持续的合规性和运营效率.
- TFM的演变对于保持科学数据的完整性和接受性至关重要.
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