EPTTS

保护埃及的药品供应链:EPTTS框架

EPTTS 框架

埃及通过埃及药品追踪系统(EPTTS)建立了全面的药品监管框架,该系统由卫生和人口部监督。这一开创性计划代表了埃及对通过确保整个药品供应链中药品的真实性、安全性和可追溯性来保护公共健康的承诺。

埃及药品法规的关键原则

符合 GS1 标准的序列化

EPTTS要求使用GS1标准对药品进行序列化,要求每个辅助包装都带有唯一的2D DataMatrix条形码。这种标准化方法可确保每件药品都带有关键的识别元素,包括全球贸易项目号 (GTIN)、批号、有效期和唯一序列号,从而可以在整个分销网络中进行精确跟踪。

端到端供应链可见性

埃及的监管框架涵盖制药生态系统的所有参与者,包括制造商、合同制造组织、分销商、批发商、药房和医院。这种全面的方法可以实现从生产到患者的不间断的可见性,建立监管链,从而显著降低假冒产品进入合法供应链的风险。

基于事件的可追溯性系统

EPTTS 在产品的整个生命周期中监控 12 个不同的 EPCIS(电子产品代码信息服务)事件,包括调试、运输、接收、包装、拆包、分发和召回。这种基于事件的跟踪方法可确保每个过渡点的实时问责制和透明度,从而可以快速识别违规行为,并在必要时进行有效的召回管理。

分阶段实施方法

埃及采取了战略性的分阶段实施EPTTS,首先是涉及关键利益相关者的试点计划。此次量化部署承认了系统的复杂性,同时支持基于实际应用的持续改进。EPTTS不是一次性项目,而是一项持续的转型计划,旨在使埃及的制药行业与全球标准保持一致。

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

Speak With a Compliance Expert

LSPedia 在 EPTTS 合规方面的专业知识

驾驭埃及的药品法规需要专业知识和技术能力。LSPedia提供根据EPTTS框架的独特要求量身定制的全面解决方案。我们的平台可与您的现有系统无缝集成,以实现符合 GS1 的序列化,简化 EPCIS 事件报告,并确保供应链的完整可见性。凭借LSPedia的专业知识,制药公司不仅可以实现监管合规,还可以在整个埃及市场实现运营效率和增强产品安全性。我们的专业团队提供持续的支持、系统更新和监管监控,以确保随着EPTTS框架的发展持续合规。retryClaude可能会犯错误。请仔细检查回复。

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