金果实业 | 携手意大利权威专家,开启ISO 15378国际认证新征程

网站编辑:浙江金果实业有限公司 │ 发布时间:2025-03-20 

金果实业 携手意大利权威专家,开启ISO 15378国际认证新征程

 

【全球视野·品质领航】为全面提升药品初级包装材料质量管理体系,金果实业特邀深耕制药包装领域20服务全球TOP药企意大利ISO国际认证权威专家团队,开展系统性培训与指导,助力企业打造国际化合规标杆,赋能药品包装安全与全球竞争力  

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第一阶段:理论筑基·标准解码

核心内容:ISO 15378标准深度解析(风险管理、材料管控、生产过程规范等)

专家赋能:意大利专家结合欧盟GMP实践经验,剖析国际法规动态与行业案例

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第二阶段:实践落地·流程优化

核心内容:生产全链条诊断(原材料采购→工艺控制→成品检测)内审员专项培训、体系持续改进机制搭建

专家赋能:现场模拟审核、缺陷分析与改进方案定制意大利团队全程陪跑,全部按照国际标准的调整,确保次性通过认证

关键工序合格率提升至99.5% 以“零缺陷”标准守护药品安全,助力中国智造走向世界获取ISO 15378证书建立国际化质量管理长效机制  

 

 

开启全球高端药包材供应链  

为合作伙伴提供更高合规保障,赋能药企全球化布局  

 

JinGuo Industry | Collaborates with Italian Authority Experts to Embark on New Journey Toward ISO 15378 International Certification

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Global Vision · Quality Leadership

 To comprehensively elevate the quality management system for primary pharmaceutical packaging materials, JinGuo Industry has invited a team of Italian ISO international certification experts with 20 years of experience in serving global top pharmaceutical companies. This collaboration will provide systematic training and guidance, empowering the company to establish an internationally compliant benchmark and enhance pharmaceutical packaging safety and global competitiveness!  

 

Phase 1: Theoretical Foundation · Standard Decoding

- Core Focus: In-depth interpretation of ISO 15378 standards (risk management, material control, production process specifications, etc.).  

- Expert Support: Italian experts, leveraging EU GMP practices, will dissect international regulatory trends and industry case studies.  

 

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Phase 2: Practical Implementation · Process Optimization

- Core Focus: Comprehensive diagnosis of the entire production chain (raw material procurement → process control → finished product testing), specialized training for internal auditors, and establishment of a continuous improvement mechanism.  

- Expert Support: On-site mock audits, defect analysis, customized improvement plans, and guidance from the Italian team to ensure full compliance with international standards and a one-time certification success.