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LIVZON Pharmaceutical Group: Clear Path to Production Using PharmaSuite
 

LIVZON Pharmaceutical Group: Clear Path to Production Using PharmaSuite

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    LIVZON Pharmaceutical Group: Clear Path to Production Using PharmaSuite LIVZON Pharmaceutical Group: Clear Path to Production Using PharmaSuite Presentation Transcript

    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Rev 5058-CO900DLivzon Pharmaceutical GroupPharmaSuite Application in New P07 plantDong HetianIT manager2013-6-9
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved. Livzon Pharmaceutical Group Inc., founded in 1985 Is a comprehensive pharmaceutical enterprise integratingdevelopment & research, production and sales. Livzon has 9 GMP production plants located in Guangdong,Shanghai, Sichuan, Fujian, 3 GAP planting bases for TCM productionlocated in Shanxi, Gansu, Yunan of China, with total 5,000employees Livzon: Top 200 Asian SMEs by Forbes Top 20 of the Chinese medical industry Top 20 Most Competitive Listed Medical & PharmaceuticalCompaniesLivzon Pharmaceutical Group
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Livzon Pharmaceutical Group
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Livzon Pharmaceutical Group
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Major Challenge• Livzon’s new plant requires material to move multipletimes between different floors without direct contact withthe operators.• In the highly automated production lines, acomprehensive software solution is required to control theprocess of the material movement, monitor the productionline, supervise the operation, and ensure the qualitycompliance.• Livzon needed an MES that integrated with enterpriseresource planning (ERP) and other business systems.
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.P07 Plant major features6Drug forms TabletCapsuleGranulesSpecifications 54Process Route 17
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.One Typical Production Process
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.PharmaSuite SolutionLivzon, the system included production management, material track and trace, weigh anddispense, and validation.Production tracking: Comprehensive finished good genealogy ensures the traceabilitythroughout the entire production process.Process control compliance: The MES system enforces the production processes andprocedures, tracks the production process in real-time, collects and preserves processknowledge. The system manages the raw materials movement using bar code labels,recording the material consumption in the entire production and providing completevalidation documentation.Production management visibility: MES provides a unified, real-time informationmanagement system, integrating different information, including man/materials/machineryand methods. Managers can access the information in different systems to facilitatecomparison, analysis, tracking and monitoring, and have a comprehensive understandingof the overall production status.Validation: according to GAMP5, RA also provides validation service, whole set ofvalidation document
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved. Role-based by design Graphical workbench Re-usable building blocks Real-time verification of recipe Ease of integration S88-aligned master recipes S88- aligned workflows Support of S95 Open content SDK for 3rd-party building blocksRockwell Pharmasuite key features-Recipe Designer
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved. “Right first time” on the shop floor Role-based by design Intuitive and consistent UI to drive operator 2D Barcode support Material, Equipment tracking Equipment interface (Scale, OPC, ...) Process guidance Exception management Ease of integration S88 control recipe Real-time equipment integration Open content 3rd-party building blocksRockwell Pharmasuite key features-Production Execution
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved. Real-time „Review by Exception“ Role-based by design Quality dashboard Review by exception Workflow-driven review process Ease of integration Batch record - aligned with S88/B2MML XML-based reporting Archiving with DMSRockwell Pharmasuite key features-Production Review
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.MES interface with Automation system• LiveData communication• Easy & quick• Error proteck• Integrated architecture
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.MES Software ListDescription QtyFTPS Current Client Lic 50FTPS W&D 1FTPS EBR 1FTPS ProductionCentre Enterprise Edition (Jboss) 1FTPS BASIC 1FTPS ANNUAL FEE 1FTPS VALIDATION 1FT KEPWARE 1
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Solution hardware architecture
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Mapping to GAMP® 5 V-ModelSWInstallationVerificationAcceptanceTestsSWOperationVerificationImpactand RiskAssessmentTraceabilityMatrixValidationPlan TestReportValidationReportTestPlan FitGapAnalysis“IQ”“OQ”“PQ”outdated terms!
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Validation document计划阶段 / Planning风险分析 (Risk Assessment),验证主计划 (Validation Master Plan), 质量计划 (Quality Plan),测试计划 (Test Plan), 配置管理计划 (Configuration Management Plan)用户需求说明 (User Requirement Specification), 功能/设计说明 (Function/ DesignSpecification), 需求追踪矩阵 (Requirement Traceability Matrix)组态/编程开发 (Configuration/Coding Building),源代码审核 (Source Code Review),版本控制 (Version Control)整合测试 (Integrated Test), 工厂验收测试 (Factory Acceptance Test), 现场验收测试 (SiteAcceptance Test),安装确认 (Installation Qualification), 操作确认 (OperationalQualification), 性能确认 (Performance Qualification)验证总结报告 (Validation Summary Report), 文档移交 (Documents Handover),整合全生命周期的风险分析 (Risk Assessment integrated with the life cycle),需求追踪矩阵(Requirement Traceability Matrix)说明阶段 / Specification系统开发阶段 / System Build确认阶段 / Verification报告阶段 / ReportingCopyright © 2011 Rockwell Automation, Inc. All rights reserved.
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Realtime Expectation
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Why Rockwell Mature Pharma MES platform PharmaSuite Mutiple application globally Long development history Prefessional local technical support /engineering resourse Local presales team Local professional technical consultant Local strong project engineer team Early approach to us in the development of the manufacturing line to helpdefine the project’s scope and plan Showed abundent pharma best practice /experice Professional presales introduction & communication Detailed technical proposal Expertise egineer team Good quality warranty
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Rockwell China teamThanks for hard works of Rockwell China Information Solution BDM team Rockwell Information Solution GOTC team Rockwell China Vertical industrial team TC Rockwell China geogrophy sales team Rockwell China ISPB delivering team engineer Rockwell China partner Austar engineer Rockwell China ISPB deliver team
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Thank you !
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Rev 5058-CO900DQuestions?
    • Copyright © 2013 Rockwell Automation, Inc. All Rights Reserved.Rev 5058-CO900DThank you for participating!Please remember to tidy up your work area for the next session.We want your feedback! Please complete the session survey!