验证主计划模版(共47页).doc

精选优质文档-倾情为你奉上专心-专注-专业VALIDATION MASTER PLAN验证主计划 (China) Co., Ltd.MANUFACTURING PLANT有限公司工厂PREPARED BY:QA MANAGER制定人：QA 经理CHECKED BY:HEAD OF QA审核人：质量经理APPROVED BY:批准人：VERSION/版本：VALID DATE/生效日期精选优质文档-倾情为你奉上专心-专注-专业Content/目录目录1.INTRODUCTION 简介-51.1.Validation policy 验证方针 -51.2.Aim of the Validation Master Plan (VMP) 验证主计划（VMP）的目的-52.LOCATION 位置 -73.RESPONSIBILITIES 职责 -74.VALIDATION: FLOW SHEETS AND DEFINITIONS 验证：流程和定义-114.1.General criteria 一般标准-114.2.Validation flow chart 验证流程图-124.3.Operative scheme 实施程序-135.ACCEPTANCE CRITERIA 接收标准：-175.1.General acceptance criteria for qualifications 确认的一般接收标准-175.1.1.Design Qualification (DQ) 设计确认（DQ）-175.1.2.Installation Qualification (IQ) 安装确认（IQ） -175.1.3.Operation Qualification (OQ) 运行确认（OQ） -185.1.4.Performance qualification (PQ) 性能资料（PQ）-195.2.Specific acceptance criteria for qualifications 确认的专属接收标准 -195.3.General acceptance criteria for process validations 工艺验证和一般接收-195.4.General acceptance criteria for cleaning validations 清洁验证的一般接收标准-255.4.1.Chemical check 化学检查 -255.4.2.Microbiological check 微生物检查 -266.QUALIFICATIONS AND VALIDATIONS LISTS 确认和验证清单-276.1.List of GMP related building and building services qualifications including level of validation GMP相关的建筑物和厂房服务系统确认清单包括各层水平的验证-276.2.List of equipment qualifications including level of validation and critical items 设备确认验证层次的重要项目之清单-286.2.1.MANUFACTURING EQUIPMENT 生产设备-286.3.List of Quality Control Equipment including the level of qualification 质量控制设备清单-306.3.1.Quality Control equipment Chemical Laboratory 质量控制设备-化学试验室-306.3.2.Quality Control equipment IPC 质量控制设备-中间过程控制室 -316.3.3.Quality Control equipment Microbiological Laboratory 质量控制设备 微生物试验室 -316.4.Analytical method validation 分析方法验证-32精选优质文档-倾情为你奉上专心-专注-专业6.5.List of products with manufacturing steps 产品清单及生产步骤-336.6.List of products including level of process validation 拟进行验证的产品清单 -346.7.Maintenance of validation 验证维护 -357.DOCUMENTATION 文件-367.1.Validation protocol 验证方案 -367.2.Validation report 验证报告-367.3.Deviations 偏差-377.4.Document structure for DQ, IQ, OQ, PQ. DQ, IQ, OQ 及 PQ 的文件结构-377.5.Documents numbering 文件编号 -397.6.Document filing of qualification and validation protocols and reports 确认和验证方案及报告的归档-398.STANDARD OPERATING PROCEDURES 标准运作程序-399.GLOSSARY 术语 -3910.GUIDELINES-45ANNEX 1. ORGANIZATION CHART 附录 1：组织机构图 -46ANNEX 2: LIST OF ROOMS IN GMP AREA 附录 2：GMP 房间清单 -47ANNEX 3: Annual validation plan 附录 3：年度验证计划 -50精选优质文档-倾情为你奉上专心-专注-专业1. INTRODUCTION简介简介1.1.Validation policy验证方针验证方针Validation is a part of our quality policy. We believe in it as a concept which provides both regulatory compliance and cost benefits. It is the responsibility of the Head of QA to assure that the compliance with this VMP is maintained. Plant Director to assure the resources necessary to achieve the compliance with this guideline shall be provided within the operating budgets of all organizational units.验证是我们质量方针的组成部份。

我们把它看成是既能保证符合法规又能节约成本的一个理念质量经理应保证有关工作与该验证主计划的符合性得到适当的维护工厂总监保证该验证主计划所必须的资源应该在整个组织范围内作为其运作预算得以提供Validation is an important part of the Quality Assurance system of the company and an essential element of Chinese and International GMP standards. This plan defines the nature and extent of testing expected to be done on each system to get documented evidence, for all critical parts of the solids manufacturing site of-. It provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.验证是公司质量保证体系的一个重要组成部份，也是中国和国际 GMP 规则的基本要素。

该计划为-固体生产工厂的所有重要部分，确定了在每一个系统中计划进行的测试的内容和水平，以获得书面的文件记录证明某一特定的生产程序能持续生产出符合预期规格要求和质量特性的产品具备了高度保证Involved departments are committed to carry out the described programs according to this fixed master plan.相关部门应根据确定的主计划中说明的程序进行工作1.2.Aim of the Validation Master Plan (VMP)验证主计划（验证主计划（VMP）的目的）的目的The aim of the VMP is to describe the validation program to be carried out in a structured way according to formally authorized standardized working and administrative procedures. The VMP is a management instrument for planning, implementing and controlling the validation activities.VMP 的目的是描述根据正式授权的、标准化的工作和管理程序，而以一确定的方式来执行的验证程序。

VMP 是计划、实施和控制验证活动的管理工具The VMP: VMP 包括：Identifies systems, building, installations, equipment, procedures and processes involved in validation;说明验证中的系统，建筑，安装，设备，程序和过程；Defines required validation activities for each item; 确定每一项目所要求的验证活动；精选优质文档-倾情为你奉上专心-专注-专业Describes the trials and analytical tests for each part;描述每一部分的试验和分析测试；Outlines the test procedures and protocols to be followed to accomplish validation;确定完成验证工作所要依照的测试程序和方案；Defines the acceptance criteria for validation;确定验证的接收标准；Defines responsibilities for validation;描述验证项目中的职责；Defines reporting responsibilities and requirements in order to document the work carried out and results obtained;确定报告的职责和要求，以便书面记录所执行的工作和获得的结果；Determines and manages the required capacity and time schedules for the realization of each validation project.确定和管理实现每一验证项目所要求的工作量和时间排期。

Furthermore the VMP desc。