ISPE GAMP<sup>®</sup> Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach [Chinese Translation] cover image

ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach [Chinese Translation]

Published:February 2014

Pages:116

The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. It collects and integrates information and knowledge from many disciplines and sources into a single comprehensive guideline.

  • 1 引言
  • 1.1 概述
  • 1.2 目的
  • 1.3 范围
  • 1.4 利益
  • 1.5 目标
  • 1.6 关键概念
  • 1.7 结构指导
  • 2 实现控制及合规的方法
  • 2.1 MES策略
  • 2.2 MES生命周期
  • 2.3 质量风险管理
  • 3 项目阶段
  • 3.1 引言
  • 3.2 计划
  • 3.3 需求定义
  • 3.4 规范和设计
  • 3.5 配置和定制
  • 3.6 实施
  • 3.7 验证
  • 3.8 数据迁移
  • 3.9 报告和发布
  • 3.10 支持流程
  • 4 运行阶段
  • 4.1 引言
  • 4.2 操作变更控制和配置管理
  • 4.3 安全
  • 4.4 性能监视
  • 4.5 软件和数据的备份与恢复
  • 4.6 记录保存、归档和检索获取
  • 4.7 业务连续性和应急计划
  • 4.8 定期审查
  • 5 附录1 – MES合规性、项目及运行活动的协调
  • 5.1 引言
  • 5.2 结构化程序
  • 5.3 项目职责
  • 6 附录2 – MES规划
  • 6.1 引言
  • 6.2 挑战
  • 6.3 业务驱动力
  • 6.4 项目规划
  • 6.5 战略规划
  • 6.6 功能域
  • 6.7 应用程序选择
  • 6.8 MES实施计划
  • 6.9 风险考虑因素
  • 6.10 角色和职责
  • 6.11 法规
  • 6.12 数据管理计划
  • 6.13 系统架构
  • 6.14 资金投入
  • 7 附录3 – 域方法
  • 7.1 引言
  • 7.2 应用域到系统设计
  • 7.3 域对风险管理和验证的影响
  • 7.4 现有系统的域方法的实现
  • 7.5 域方法的优点总结
  • 7.6 扩展谱系的实例
  • 8 附录4 – 开发MES的实施策略
  • 8.1 引言
  • 8.2 开发策略的考虑和概念
  • 8.3 横向实施策略
  • 8.4 纵向实施策略
  • 8.5 应用控制策略
  • 8.6 核心团队活动
  • 8.7 部署MES的核心功能
  • 8.8 分阶段部署
  • 8.9 实施中的控制
  • 8.10 其它考虑因素
  • 8.11 生命周期阶段的相互关系
  • 9 附录5 – 应用和系统的选择方法
  • 9.1 引言
  • 9.2 策略方法的开发
  • 9.3 范围和理由
  • 10 附录6 – 系统集成:接口和接触点
  • 10.1 引言
  • 10.2 数据
  • 10.3 中间件
  • 10.4 ERP接口
  • 10.5 过程自动化
  • 10.6 批处理系统
  • 10.7 实验室信息管理系统
  • 10.8 电子记录和签名的接口问题
  • 11 附录7 – 电子生产记录系统
  • 11.1 引言
  • 11.2 建立等效的电子功能
  • 11.3 辅助记录
  • 11.4 配方管理和测试
  • 11.5 EPRS基本功能
  • 11.6 EPR模块
  • 11.7 补充的ERP过程
  • 11.8 简化流程
  • 11.9 EPRS方法
  • 11.10 EPRS 优点
  • 12 附录8 – 异常审查
  • 12.1 定义和理由
  • 12.2 生产报告内容的考虑因素
  • 12.3 新系统或升级系统的考虑因素
  • 12.4 分阶段部署
  • 12.5 系统定期重新评估
  • 13 附录 9 – 登录、识别和签名的方法
  • 13.1 引言
  • 13.2 物理方面
  • 13.3 逻辑方面
  • 14 附录10 – 人员和工作流的考虑
  • 14.1 引言
  • 14.2 标准接口和强制的运行顺序
  • 14.3 心理和文化方面
  • 14.4 用户界面考虑
  • 15 附录 11 – 符合WIP 物料管理
  • 15.1 核算与GxP的方法
  • 15.2 管理物料库存和状态
  • 15.3 配送(制药)和物料消耗的考虑
  • 16 附录 12 – 配置管理
  • 16.1 引言
  • 16.2 运行的定义和关键环节
  • 16.3 MES域的所有权和生命周期
  • 16.4 功能和产品配置
  • 16.5 协调系统发布的流程
  • 16.6 MES域中的配置管理
  • 16.7 系统识别和命名
  • 16.8 基于命名的安装
  • 16.9 基础设施追踪
  • 16.10 建立配置规则
  • 17 附录 13 – MES标准和模型
  • 17.1 引言
  • 17.2 针对行业概况的MES功能
  • 17.3 ANSI/ISA-95企业控制系统集成
  • 17.4 XML和B2MML
  • 17.5 ANSI/ISA-S88
  • 17.6 国际供应链协会的SCOR模型
  • 17.7 国际的MESA
  • 18 附录14 – 参考文献
  • 18.1 参考文献
  • 18.2 参考书目
  • 19 附录15 – 词汇
  • 19.1 缩略语
  • 19.2 定义

No Acknowledgments available

The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach, was created to help to facilitate the planning, development, and testing of Manufacturing Execution Systems (MES) that may be used to support manufacturing in life sciences organizations.

This Guide is intended to help bridge the gap between the ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance and the ISPE GAMP® Good Practice Guide: Validation of Process Control Systems for supporting and maintaining MES environments. The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach should be read in conjunction with these Guides.

GAMP® guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. This Guide has been developed by pharmaceutical industry professionals to meet these goals and principles.

This Guide takes a life cycle approach to examining MES, not as an application, but as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization.

As individual systems evolve to become broader in scope, a system considered to be business-oriented may have functionality which connects to Manufacturing Operations and potentially affects product quality. Therefore, the integration of functions may require the application of testing principles for process control systems to a system considered to be business-oriented. The definition of a ‘business system’ may become difficult, and it may become necessary to create logical boundaries around functionality across systems to define categories of use and criticality.

The domain approach presented in this Guide provides an approach to manage life cycles for the integrated manufacturing environment.

The authors of this Guide have built upon ANSI/ISA 95.00.01-2000, Enterprise-Control System Integration, Part 1; Models and Terminology, an industry independent standard for improved integration of manufacturing through communication that defines common terminology and a consistent set of models that emphasize good practices for integration of control systems with other enterprise systems.