首页 GAMP4(中英)

GAMP4(中英)

举报
开通vip

GAMP4(中英)Technical Document Review: 技术文件回顾: Good Automated Manufacturing Practice (GAMP) Guide for the Validation of Automated System 优化的自动化制造规范—自动化系统验证指导 Introduction 简介 This document aims to review the Good Automated Manufacturing Practice Guide for the Validation...

GAMP4(中英)
Technical Document Review: 技术文件回顾: Good Automated Manufacturing Practice (GAMP) Guide for the Validation of Automated System 优化的自动化制造 规范 编程规范下载gsp规范下载钢格栅规范下载警徽规范下载建设厅规范下载 —自动化系统验证指导 Introduction 简介 This document aims to review the Good Automated Manufacturing Practice Guide for the Validation of Automated System (GAMP 4), December 2001, published by the ISPE. To learn more about GAMP or to place an order, visit www.ispe.org The content of this summary hopes to identify the top level requirements of the steps undertaken to validate an automated manufacturing process, this includes environmental monitoring systems, autoclaves, filling lines, and any other process governed by electronic control rather than a manual process. 本文件旨在于对2001年12月由ISPE出版的GAMP4的回顾学习。若要更深入的了解GAMP或购买,请访问www.ispe.org网站,本概要希望能帮助用户充分理解在自动化系统验证过程中的高要求。这些系统包括 环境监测系统,高压灭菌填充线,除手动程序外其他任何受电子控制的的过程。 In the late eighties and early nineties the validation of automated system in pharmaceutical manufacturing assumed a much greater importance than had previously been the case. Although regulatory guidelines concerning the use of such automated systems had been available for some time, the systems had been subject to less regulatory scrutiny than other areas of production and were deemed to be less mature than more conventional areas. An industry group was set up to promote the understanding of the industry requirements. That group was made up of several major pharmaceutical manufacturers and become the GAMP Forum. In 2000, GAMP became formally affiliated with ISPE as a technical sub-committee within the organization. The guide has been broadened to incorporate a closer relationship with the ideals of system validation. The following sections identify the top-level features of the GAMP guide. 80年代后期90年代初,自动化系统验证在制药行业中已经显得越来越重要,尽管本指南对关于使用自动化系统有时是可行的,但由于缺乏详细审查(相对其他生产领域)有;因而相对其他传统领域来说,被认为是不成熟的。因此成立了一个产业集团推广人们对产业要求的理解,这个集团由几大主要的制药企业组成,并在2000年成立了GAMP论坛,随后GAMP正式附属ISPE这个组织中的一个技术委员会。本指南已做多次拓展以使之与自动化系统验证更紧密结合,以下是有关GAMP指南的发展情况: GAMP 1.0 →GAMP 2.0 → GAMP 3.0 →GAMP 4.0 Mar 1995 Mar 1996 Mar 1998 Mar 2001 Original document created by comments of 31 companies, originally UK 原始文件是在英国由31个公司联合起草。 Revision following comments from Europe and USA 以下是欧洲与美国的修正版 Revision includes Supplier and User sections 修正版包括供应商和用户 Broadened scope in line with regulatory requirements and new industries. 扩展了相关要求和新领域应用 More responsibility on Users 对用户提出了更多的要求 Validation Overview 验证概述 Validation is applied to many aspects of pharmaceutical manufacturing, including instrumentation, systems cleaning etc. In each case the objective is to produce “documented evidence, which provides a high degree of assurance that all parts of a facility will consistently work correctly when brought on-line”. Traditionally, validation has consisted of the following: 验证应用于制药行业的许多方面,例如:仪器,系统清洁等。但不管用于哪方面,他们的目的都是要提供文件性证明,这些证明能够充分保证设备运行时工作的一致性。一般的来说,包括如下部分: Design Qualification (DQ) - Documented evidence that the design of the system meets Requirements 设计验证—文件性证明能证明系统符合要求 Installation Qualification (IQ) - System has been installed correctly 安装验证---系统应已正确安装 Operational Qualification (OQ) - System operates according to design 操作验证---系统操作与设计相符 Performance Qualification (PQ) - System meets design criteria, and operates according to Requirement 性能验证---系统符合设计标准,操作符合要求 Traditionally, each of the ‘Qualification’ sections has contained both the specification and the test protocols aimed at verifying that each stage is completed. The term Validation Protocol is often used when referring to these documents. 一般来说,各方面的验证包括要求和 方案 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 两个层面,目的是校验各步骤的完整性, 涉及这些文件时,验证方案经常会被使用。 The guide recommends the use of supplier documents, if suitable. Documents provided by the supplier will simplify the overall validation process. Many of the tests performed by suppliers meet (or exceed) the site requirements for IQ and OQ, and often become reference documents for the User to direct a testing matrix toward. 本指南推荐使用供应商提供的文件,如果合适的话。供应商提供的文件将使整个验证过程简单化,供应商执行的检测往往符合甚至超过对IQ和OQ的要求。同时也是对用户自己检测的惯用参考文献。 System Documentation 系统文件 The documentation for an automated system should follow the “V” model. This model shows how the three main qualification activities can be linked back to the design process. The V model principle works well for smaller straightforward systems, such as a monitoring system, which has little or no integration into site wide services. 自动化系统使用的文件应依据“V”型模式, 这种模式显示了3种主要的验证活动如何与设计程序相联系。“V”型模式对小型简单的系统来说,效果很好,例如像监控系统这种涉及一点或不涉及综合性大范围服务的系统。 The document which initiates the validation process is the User Requirement Specification (URS). This describes the equipment or system as it is supposed to work and is normally written by the system user. The original version issued for quotation should normally contain the essential requirements (musts) and the desirable requirements (wants). The final version then accommodates all the musts, which can be met, and any of the wants, which also can be satisfied. The URS is now a standard document required for companies to meet the ISO9001:2000 standards. 用户要求描述(URS)是验证程序的初始文件,他一般由用户编写,描述了对设备和系统的要求。最初版本一般包括必须要求和期望要求,最终版本则包含所有能够被满足的必须和期望要求。URS现在已经成为达到ISO9001:2000标准的标准文件。 The Function Design Specification (FDS or FS) is normally written by the supplier and describes the functions of the equipment or system. The FDS links to the OQ as each major parameter stated should be tested. The FDS is also a standard output document required by ISO 9001: 2000. 功能设计要求(FDS / FS)一般由供应商编写,对设备和系统的功能进行描述,要求操作验证中的各主要参数应该进行检测。FDS同样已成为ISO 9001: 2000的标准输出文件。 The documentation then includes the system build and testing of the installed components. These documents are the testing qualifications IQ, OQ and PQ. At given stages during the lifecycle of the project, planned and systematic reviews should be performed. The design reviews evaluates the deliverables against standards and requirements. The overall validation lifecycle is therefore: 这些文件包括系统建设和安装组件的测试,有IQ, OQ 和 PQ.文件,在项目生命周期内,给定一定的条件,根据计划系统地进行检测,这些检测将根据标准和要求对交付使用进行评估。对生命周期的全面验证如下 : Development Activities 验证项目 Validation Activities 验证活动 User Requirements Specification URS Functional Specification 功能要求 Planning and Specification 计划和要求 Validation Plan 验证计划 Supplier Assessments 供应商评估 Design Reviews 设计校验 Hardware Design Specification 硬件设计要求 Software Design Specification 软件设计要求 Network Design Specification 网络设计要求 Package Configuration Specification 包装要求 Design 设计 Design Reviews 设计校验 Hardware Manufacture and Assembly 硬件制造与组装 Code Software Modules 编码软件模块 Network Manufacture and Assembly 网络组建 Construction 结构 Construct Reviews 结构验证 Code Reviews 代码验证 Hardware Testing 硬件测试 Software Module Testing 软件模块测试 Software Integration Testing 软件综合测试 Package Configuration Testing 包装测试 Testing 测试 Monitor Supplier (Testing done at this level can contribute to IQ/OQ) 供应商监控(从此层面上测试有助于IQ,OQ验证) Hardware Installation 硬件安装 Software installation 软件安装 Network Installation 网络安装 Hardware Acceptance Testing 硬件可接受测试 Network Acceptance Testing 软件可接受测试 Installation 安装 Installation Qualification 安装验证 System Acceptance Testing 系统可接受测试 Acceptance Testing 可接受测试 Operational Qualification 操作验证 Performance Qualification 执行验证 Maintenance Validation Report 维护验证报告 Change Control 变更控制 Operation 运行 Validation Report 验证报告 Maintaining the Validated state 维持验证状态 Maintaining the Validated State 维持验证状态 When a system is validated and in operation, measures should be taken to ensure that the system remains in a validated state. This maintenance not only involves the integrity of the hardware and software, but also the documentation. The maintenance of a validated system includes many activities, which the User is responsible for. 当一个系统经验证后处于可运行状态,应采取各种措施以保证系统处于验证合格状态,维护不仅包括全部的硬件和软件,还包括相关文件,对验证系统的维护包括许多工作,用户必须对此负责。 System Operational Procedures (SOPs) 系统操作程序 SOPs should be established to define the use and support of the automated system. SOPs should be approved prior to use. 系统操作程序必须支持自动化系统,必须在使用前进行核对。 Training 培训 Training plans should be established for use and support of the system. These plans need to consider the training of all users, technical and support. 培训计划应该与系统支持与使用相符合,需要考虑所有的使用者和相关技术和支持。 Problem Management & Resolution 问题管理与解决 How the faults in the software / hardware are initiated, reviewed, prioritize, and closed. 硬件/软件故障是如何产生的,进行回顾,优先级排序和解决 Service Agreements 服务 协议 离婚协议模板下载合伙人协议 下载渠道分销协议免费下载敬业协议下载授课协议下载 All service agreements should provide a formal approach to the support of an automated system. It should be unambiguous, define how the service is to be provided and provide a means of measuring the performance of the support. 所有的服务协议都应提供一条正式的途径以支持自动化系统 Backup and Recovery 备份与恢复 How the system is backed up, where the copies go, and at what frequency the archives are made. 系统如何备份,备份件放在何处,文件多久备份一次。 Configuration Management 结构管理 Procedures to establish the baseline system (close of Validation), control of configuration (workarounds and patches), ensure the completeness of changes, control and storage of the revised items. 程序要建立基线系统,控制结构(工作区与小站),修正项目的更改,控制和储存的完整性。 Operational Change Control 操作变更控制 All changes proposed during the operational phase should be subject to formal change control processes. 所有在操作阶段的变更都应遵循正常的变更控制程序 Security Management 安全管理 企业安全管理考核细则加油站安全管理机构环境和安全管理程序安全管理考核细则外来器械及植入物管理 Automated systems and data should be protected against willful or accidental loss or damage. The regulations for 21 CFR 11 surpass the outlines given in GAMP 4. 自动化系统和数据应采取保护措施以防任意破坏,以外丢失和损坏,21联邦法规 第11部分要求比GAMP 4中的规定更为严格 Performance Monitoring 执行监控 The impact of system failure will vary depending on the criticality of the automated system. Where possible, monitoring of the performance of the system should be done to capture problems in a timely manner. 系统故障的影响取决于系统的危险程度,如果可能,监控系统应能及时捕获问题所在。 Record Retention & Archiving 记录的保持与存档 SOPs for the retention archiving and retrieval of data should be established and documented. 应建立记录的保持与存档和数据恢复的标准操作程序并备份 Business Continuity Planning 作业的连续性 This is aimed at disaster recovery and contingency plans should a system fail. Topics include catastrophic failure of either the software or hardware and alternative means of manufacturing. 本条款旨在系统失效时的灾难性恢复意外事故计划,包括硬件和软件或其中任意一项在在生产过程中遭遇灾难性故障 Periodic Reviews & Evaluation 周期性检测与评估 These are done to verify that a system remains in a validated state and is being operated in accordance with SOPs. 本措施是为检核系统处于有效状态并能依据标准操作程序操作。 System Retirement 系统更新 Due to the volume of data, decommissioning a system can be a major task. Considerations should be given to a procedure to replace the system, retained records, which GxP records are required, migration of data to new systems, retention of old hardware to be able to read the records and system archiving. 由于数据的容量,系统的更替将成为一项重要任务,必须考虑系统程序的可替换性,保持原来的记录,把数据输入到新的系统内,硬件应仍能读取系统文档。 Validation Lifecycle 生命周期验证 Any system requires cooperation between suppliers and users. It is beneficial if the supplier uses a formal management system to control documentation, including the production of the software package. Users should verify that the documentation supporting the project lifecycle meets the company expectations; this is usually done via a supplier audit. Each company should have a defined policy regarding automated systems. A site wide Validation Master plan should identify the following User Responsibilities. 任何一个系统都需要供应商与用户之间的合作,如果供应商使用正式的管理系统控制文件,包括软件,这对双方都是有利的。用户应该进行校验,文件管理是否项目周期以满足公司期望,通常来说,这些将有供应商来审计。一个广泛的验证方案应明确如下用户责任。 Identify System 识别系统 Each system should be assessed and GxP systems identified 每个系统都应评估并由GxP系统识别 Produce URS 产品URS This should clearly define precisely what the user wants from the system. 应明确用户对系统的期望 Determine Validation Strategy 验证策略 Includes sections on: 包括以下方面: o Risk Assessment: Does the system require validation? How much validation is required? What aspects of system or product safety are at risk? What aspects of the system are critical to business? 风险评估:系统是否要求验证? 验证费用多少?系统或生产安全性哪方面存在危险?系统哪方面对企业很重要? o System Components Assessment: The categorization of the software and hardware components. 系统组件评估: 软件的分类和硬件的组成 o Supplier Assessment: A formal assessment of each supplier; company audit. The audit may establish that a supplier has a quality system ISO9000 and in which case this may be given as reason not to perform a site audit. 供应商评估:对每位供应商做一个正式的评估,公司审计,审计与供应公司是否通过ISO9000 相联系,若通过,则无须做现场验证。  Validation Plan 验证计划 Document defines activities, procedures and responsibilities of the project, and identifies the areas for Risk Assessment. Also included are Quality Plan and Project Plan. 文件定义了验证活动,程序和项目责任,及风险评估领域识别,也包括质量计划与项目计划。 Review/Approve Specifications 核准 The user must review and approve all specifications from the supplier, including the Functional Specification and detailed hardware and software specifications. 用户必须核实供应商提供的要求规范,包括功能要求和硬件和软件的详细信息。 Monitor System Development 监控系统 The user should monitor the project in line with milestones. 用户应监控项目各重要部分是否符合要求。 Review Source Code 检查源程序 Source Code should be adequately reviewed. This includes reviews of all development tools, policies and procedures, programming rules and testing. 源程序应充分检查,包括所有升级工具,政策和程序,规则和测试。 Review/Approve Test Plans 核准测试计划 The user must approve test plans prior to formal testing. 在正式测试前用户必须核准测试计划 Perform Testing 执行测试 The user may be used as a witness or tester for the software module & integration testing and the Hardware & System acceptance testing. 用户作为证人或测试者对软件模块与综合检测和硬件与系统可接受测试做见证 Review Test Reports 核对测试报告 The user should approve the test outputs from the formal testing. 用户应该对正式测验进行核对 Product Validation Report 生产验证报告 The Validation Report should summarize all the deliverables and activities and provides evidence that the system is validated. 验证报告应对所有可交付使用性,验证活动及系统可行性证据进行综述。 System Retirement 系统更新(退役) The user should manage the replacement or withdrawal of the system from use. Two types of system are identified in the guide are: 用户应能处理系统更换问题,本指南中两种系统的识别如下: IT Systems Database packages, such as LIMS and MRPII fall into this category, it is where data is stored either fixed analytical or documentation. IT系统:数据库,像LIMS和MRPII属于此类,数据被解析或以文件形式 Process Control Systems Control systems, Monitoring systems and analytical systems fall into this category. 过程控制系统:控制系统,监控系统和 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 系统属于此类 Lifecycle Validation 生命周期验证 The guide differentiates between Embedded and Standalone process control systems. 本指南区分了植入的和独立的程序控制系统 Embedded systems are microprocessor based systems such as programmed Integrated Circuits (IC), Programmable Logic Controllers (PLC) or PC with the sole purpose of controlling or monitoring a piece of manufacturing or analytical equipment; examples are filling machines, packaging machines and particle counters. 植入的系统是以微处理器为基础的系统,例如像程序集成电路,PLC, 微机等有一个核心的目的对生产的某个部分进行控制和监督或者对设备进行分析,像填充机,包装机和粒子计数器。 Standalone systems are either custom or configured, self-contained systems, which are components of an automated manufacturing process application. They are delivered as free standing computer systems, separate to the plant equipment. Examples of standalone systems are: 独立的系统是定制的或设定的,自带的系统,是自动化生产应用程序的组成部分,他们是电脑系统的一部分,与工厂设备不一样,例如: Multi-loop controllers or PLCs controlling part of a process 多回路控制器和PLC程序的控制部分 Supervisory Control and Data Acquisition (SCADA) systems (Pharmaceutical Net fits here). 监控和数据获取系统 Distributed Control Systems (DCS) 分布式控制系统 Building Management Systems (BMS) 积木式管理系统 The pre-requisites for validation at minimum costs for both types of system are the same, following the same basic principals to system lifecycle. 这两种系统对验证来说,同等重要,以下是系统生命周期主要流程。 Planning 计划编制 The Thee GAMP ‘‘V’’ Modeell GAMP ‘‘V’’型模式 V - MODEL for Specifications, Build and Testing 要求,组建和测试的“V”型模式 User Requirement Spec. 用户要求明细 Validation Plan 验证计划 Quality Plan 质量计划 Functional Specification 功能要求 General Database 总数据库 HW Design Specification 硬件设计要求 Electric/Pneumatic/Automation/Control电动/气动/自动/控制 SW (Module) Design Specifications 软件设计要求 PLC/OP/PCS/Fieldbus/SCADA/LAN/ PLC/OP/PCS/现场总线/监控和数据获取系统/局域网 custom built modules 定制模块 HW Component 硬件组成 Acceptance Tests 可接受测试 SW Module Testing 软件模块测试 HW Integration Test 硬件综合测试 SW Integration Test 软件综合测试 System Integration Test As Built Documentation系统综合测试与建设文件相符 System Acceptance Validation summary reports 系统验证可接受总结报告 TEST SPECIFICATIONS 验证要求 FAT (Report) FAT 报告 SAT (Report) SAT报告 HW Construction 硬件结构 HW Purchase 硬件采购 SW Implementation 软件运行 Reviews 核对 (PQ) 执行验证 OQ 操作验证 IQ 安装验证 During the planning phase the user assesses the supplier’s quality system. The supplier should develop a Quality and Project Plan. The planning phase may include or relate to mechanical and electrical activities as well as automation. The supplier should assist with the Risk Assessment, reviewing the potential impact of system failures. 在计划编制阶段,用户需要对供应商的质量体系进行评估。供应商应该做一个质量和项目计划,计划编制阶段包括自动控制,机械和电气的活动或与之相关。供应商应协助风险评估,测试系统崩溃可能带来的影响 Specification and Design 要求与设计 User Requirements Spec (URS) The URS for large systems may involve the development of separate URSs, which cover all the different elements of the project. The manufacturing parameters to be controlled or monitored and the data to be generated should be clearly documented. The design and testing of hardware and software components affecting product criticality should be assessed. 一个大系统的URS包含许多个独立的URS, 他们涵盖项目的各个方面的要素,被控制和监督的制造参数和产生的数据应做成文档保存,硬件和软件的设计和测试对生产的影响应做出评估 Functional Spec (FS) 功能明细 The FS is normally written by the supplier and describes the detailed functions of the entire system, what the system will do. The FS is a contractual document and should be subject to change control. 功能明细一般由供应商编写,他阐述整个系统的功能,系统将做些什么。功能明细是契约性文件,应符合控制改变要求 Detailed Design Spec (DSS) 详细设计规范 The detailed design includes the production of the hardware, software and instrumentation. It should specify equipment schematics, Process & Instrument diagrams (P&ID), Loop schedules, Process sequences and interconnection drawings. 详细设计包括硬件,软件和仪器,应有详细的设备图表,程序和工具图表,循环进度表,程序顺序和互连图。 Hardware Design Spec 硬件要求 This document defines the architecture and configuration of the hardware, including computers, hubs, instrumentation, vacuum pumps, alarm devices etc. 本文件定义了硬件结构和配置,包括电脑,网络集线器,仪器,真空泵,警报装置等 Software Design Spec (SDS) 软件要求 The software design document (SDS) should define how the software implements the requirements of the FS. The SDS should define the logical and physical structure of the software program and the standards for the build. 软件要求文件定义了软件如何执行功能文件要求,还应定义软件程序的逻辑和物理结构及构建标准。 Instrument Spec 工具要求 The system components should be organized into a document, which makes it easy to add and move sensors around the system. 系统构成应在文件中说明,以便增加和减少系统外围的传感器 Development and Build 组建 The development activities for the system should be based upon the appropriate design documents. There are three main activities, Software Development, System Build, and Production of Engineering drawings. 系统组建应遵循合适的设计文件,主要包括三个方面:软件的组建,系统的组建和生产工程图 Design Review 设计检测 A design review involves planned and systematic reviews of the system design and development throughout the life cycle. It evaluates deliverables against standards and requirements. The process involves verifying that hardware tolerances and performance meet the requirements. The outcome of any review should be documented on a Design Review Report. 设计检测应有计划的并系统的对系统设计及系统周期做检测,根据标准和要求对交付使用作出评估,包括硬件满足要求的校验,所有的检测结构应记录在设计检测报告中。 Software Development 软件开发 The supplier should establish and maintain a formal system for controlling software production. 供应商应建立和维护一个正常的控制软件。 System Build 系统建设 For a standalone system the software, instrumentation, and regulating devices are shipped to site, inspected and installed, with the manufacturing plant equipment. 整个系统,包括软件,仪器和调节装置应在现场与设备一起检验和安装。 Software Re
本文档为【GAMP4(中英)】,请使用软件OFFICE或WPS软件打开。作品中的文字与图均可以修改和编辑, 图片更改请在作品中右键图片并更换,文字修改请直接点击文字进行修改,也可以新增和删除文档中的内容。
该文档来自用户分享,如有侵权行为请发邮件ishare@vip.sina.com联系网站客服,我们会及时删除。
[版权声明] 本站所有资料为用户分享产生,若发现您的权利被侵害,请联系客服邮件isharekefu@iask.cn,我们尽快处理。
本作品所展示的图片、画像、字体、音乐的版权可能需版权方额外授权,请谨慎使用。
网站提供的党政主题相关内容(国旗、国徽、党徽..)目的在于配合国家政策宣传,仅限个人学习分享使用,禁止用于任何广告和商用目的。
下载需要: 免费 已有0 人下载
最新资料
资料动态
专题动态
is_242588
暂无简介~
格式:doc
大小:1MB
软件:Word
页数:22
分类:
上传时间:2012-05-08
浏览量:170