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我们的流程
精益六西格玛
数据驱动的文化
以数据驱动，西氏合同制造工厂在运营的各个方面使用六西格玛流程改进工具，贯彻精益生产原则。团队内拥有黑带和绿带认证的员工，以及训练有素的精益生产负责人，积极推动变革并持续，改进所有业务职能领域的产品和工作流程。从行政流程优化到验证项目开发，西氏合同制造工厂团队不断学习和分享最佳实践，推动卓越运营。我们的目标是提高可预测性，降低成本，消除浪费，保证合规，追求更卓越的质。
质量和法规
强大的质量管理系统
医药、生物技术、仿制药和医疗器械公司相信西氏，我们提供高品质的密封包装容器、给药和制造解决方案。西氏每年生产超过400亿个组件，相当于每天生产1.1亿个每小时生产500万个。作为一家历史悠久的大体量制造商，西氏合同制造团队熟悉生产规模扩张或转移合规医疗器械所需的质量和监管制度。
关键的质量流程包括：
- 客户反馈和投诉跟踪
- 基于风险的合规质量管理体系
- 设备、软件的确认和工艺验证
- 关键绩效指标 - KPI
- 计量 - CT扫描、CMM等
- 培训
- 纠正和预防措施（CAPA）
- 供应商管理流程
验证基础设施
质量管理体系和工作人员
- 专门的质量工程/验证团队
- 经过验证的产品数据管理软件
- 来料检验能力 - FTIR、DSC、提取
丰富的验证经验
- 模塑过程
- 装配过程
- 软件（控制系统、ERP系统、计量）
西氏支持
- 西氏分析实验室
- 洁净室微生物专业知识
- TPE和橡胶配方专业知识
供应链管理
优化价值流
西氏合同制造通过优化总价值流，以更具竞争力的成本控制致力提升客户满意度。通过合作建立强大的伙伴关系是基于风险全面整合供应链的关键。供应链管理结构的基础通过以下三个关键因素不断达到精益整合：
- 计划/运营
- 采购
- 物流
西氏合同制造团队与供应商和客户建立伙伴关系，进一步为客户创造价值，为信息共享和运营改进创造了强有力的沟通渠道。
在全球ERP系统的整合支持下，利用cGMP和精益实践，西氏合同制造团队通过建立JIT、VMI和看板库存管理模式，打通供应链中的各个环节，进一步减少供应链的整体交货时间和库存，为客户创造更多价值与机遇。
专题博客
五月 29, 2020
Contract Manufacturing: An Integrated Solutions Approach
In today’s increasingly complex drug delivery and device development landscape, a reliable contract manufacturing partner can become a distinct competitive advantage for pharmaceutical and device companies. West brings together the right combination of insights and infrastructure to help our customers reduce costs, mitigate risk and accelerate path to market.
五月 15, 2020
Speed to Market with a Platform Approach
Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. West, through the Integrated Solutions platform, is ideally positioned to provide this data.
十二月 31, 2019
Combination Products: The Top Three Device Challenges
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
五月 29, 2020
Contract Manufacturing: An Integrated Solutions Approach
In today’s increasingly complex drug delivery and device development landscape, a reliable contract manufacturing partner can become a distinct competitive advantage for pharmaceutical and device companies. West brings together the right combination of insights and infrastructure to help our customers reduce costs, mitigate risk and accelerate path to market.
五月 15, 2020
Speed to Market with a Platform Approach
Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. West, through the Integrated Solutions platform, is ideally positioned to provide this data.
十二月 31, 2019
Combination Products: The Top Three Device Challenges
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
