VMP模板

***Pharmaceutical Co., LTD.
No文件编号: VMP-Document Title文件题目: Validation Master Plan验证主计划 Document
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Issue Date生效日期: Version No.版本号: 1 Page页码: 1 of 8
VALIDATION MASTER PLAN (VMP)
验证主计划
Document No.: VMP-***
文件编号：VMP-***
*** Issue Date生效日期: Version No.版本号: 1 Page页码: 2 of 8 APPROVAL SHEET
批准表格
Approval
Validation 验证Date 日期
批准
Approval
Quality Assurance 质量保证Date 日期
批准
Approval
Manufacturing 生产Date 日期
批准
Approval
总经理Date 日期
批准
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Issue Date生效日期: Version No.版本号: 1 Page页码: 3 of 8
Table of Contents
目录
1.0 Introduction 简介 (4)
2.0 Scope 范围 (4)
3.0 Responsibilities 职责 (4)
4.0 References/Associated Documents 参考/关联文件 (5)
5.0 Definitions 定义 (5)
6.0 Compliance program 符合性程序 (5)
7.0 Facility Overview 设备综述 (6)
8.0 Validation Approach 验证方法 (6)
9.0 Attachments 附件 (7)
10.0 Revision History 修订历史 (7)
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1.0 Introduction 简介
1.1 *** is a manufacturer of sterile injectable pharmaceuticals. The site will be designed and
constructed to support manufacturing of both lyophilized and liquid products. The fill/finished facility will be completed in multiple phases. To meet ***’s compliance standards and regulatory requirements, the facility will be designed, constructed, and formally commissioned and validated to verify that the manufacturing space, laboratories, utility systems, and manufacturing equipments are properly installed and operational for their intended use.
* * *是一家生产无菌注射药物。

该厂房将被设计和建造以生产冻干产品和液体。

填充/最终的设备将在多
个阶段完成。

以满足***的遵从性标准和监管要求,工厂将被设计,建造,并正式委托和验证,以验证制造空
间、实验室、公用系统和生产设备的正确安装和操作对其用途。

1.2 The purpose of this Validation Master Plan (VMP) is to outline the testing and
documentation required to validate the *** facility. The direct impact equipment and utility
systems associated with the start-up project will be commissioned and validated in order to
establish documented evidence that provides a high degree of assurance that the systems
will consistently operate according to pre-defined requirements and specifications.
Validation shall be performed using a life cycle approach (validation planning, initial validation and validation maintenance).
验证主计划(VMP) 目的就是概述测试和文件以指导验证设施。

关联到项目启动的与直接影响设备和公
用系统关联的，将被调试和验证为了建立文件证据表明并提供了高度保证，这个系统将一贯根据预定
义的要求和规格进行操作。

确认将采用一个生命周期方法(验证计划，初步验证和验证维护)。

2.0 Scope 范围
2.1 The scope of this VMP is to identify the methodologies to be utilized for the validation of the
direct impact GMP systems that support the aseptic manufacturing operation to be performed at the ***facility. This VMP document shall describe, in high-level terms, the
general approach for bringing the facility, utility systems, and process equipment/systems
into a state of appropriate current Good Manufacturing Practice (cGMP) compliance, utilizing the principles of Commissioning and Validation. The validation will be planned,
executed, and documented in accordance with the *** procedures.
验证主计划的范围是确认用于直接影响GMP系统的验证，支持无菌生产操作可以在***设施被执行。

验
证主计划文件应该在高标准的级别描述，大体的做法使设施、公用系统、工艺设备/系统处于适当的当
前良好生产规范(cGMP)标准，并利用调试和验证的原则。

文件的范围、执行并记录按照***程序。

2.2 An updated Validation Master Plan will be created to facilitate changes to validation
activities performed and to summarize all qualification for the *** project on an as needed
basis. At a minimum the VMP shall be revised and if required updated once every year.
更新的验证主计划将被创建，以促进验证活动改进，并基于需求执行和总结所有项目确认。

根据需
要，验证主计划至少每年更新一次。

3.0 Responsibilities 职责
3.1 Validation is responsible for 验证部职责:
3.2 Manufacturing/Engineering/QC Laboratories are responsible for 生产/工程/质量控制实验
室职责:
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3.3 Quality Assurance is responsible for 质量保证部职责:
4.0 References/Associated Documents 参考/关联文件
5.0 Definitions 定义
5.1 VMP – Validation Master Plan – A written and approved comprehensive plan on how
validation will be accomplished at a corporate level. The VMP covers validation activities
and the current state of validation at the site.
5.2 ***
6.0 Compliance Programs 依从性程序
Maintenance of equipment and systems in a validated state requires that certain compliance programs be established prior to the initiation of validation activities. These compliance programs include document control, training, laboratory controls, facility cleaning, environmental monitoring, calibration, preventive maintenance, and change control. All the ** personnel involved in the validation and use of the facility are trained in operations, including, for example, the use of equipment, production processes, sampling techniques, laboratory testing, good document practices, as defined in governing SOPs and validation protocols.
在验证工作开始前，维护设备和系统验证状态的依从性文件应被建立，包括文件管理、培训、实验室管理、设备清洁、环境监测、校验、预防性维护和变更管理。

**公司所有参与验证和设备操作的员工都需经过设备使用、生产工艺、取样技术、实验室检测、文件管理等方面的培训，这些文件称为SOPs 和验证方案。

Training is documented in accordance with the governing SOP.
培训根据批准的SOP进行记录。

Validation is an ongoing effort, thus it is essential that change control and requalification criteria be followed as per *** SOPs. It is the responsibility of the system owner and/or the validation department to document any modification, change, discrepancy or deviation to the validated system on a modification/change/discrepancy control form in accordance with applicable SOPs. An assessment is made prior to any modification, change, or deviation to the system to determine if requalification/revalidation is required. If requalification/revalidation is required, an assessment is made to determine that all items were satisfactorily completed, properly documented, and meet ** and regulatory requirements.
验证是一项持续性工作，因此，变更控制及再验证标准相对**sop规定标准的符合性是极其重要的。

系统管理者和验证部门的职责就是将所有的修正、变更和偏差形成文件，根据适用的SOPs，以修正/变更/偏差表的形式，纳入到验证系统中。

在修正、变更或偏差发生之前，应先进行系统评估以确定是否需要再确认或再验证。

若需要，则要通过再评估确保所有项目都完全满足要求，文件规范，并符合**公司的控制标准。

This section provides an overview of each of the compliance programs, i.e. document control, training, lab controls, facility cleaning, environmental monitoring, calibration, preventive maintenance, and change control.
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此部分提供每个依从性程序的综述，例如，文件管理、培训、实验室管理、设备清洁、环境监测、校验、预防性维护和变更管理。

7.0 Facility Overview 设备综述
7.1 The buildings, facilities, equipment, and systems associated with the project will be
designed and installed to comply with US Federal, European, and Chinese codes, as well
as published standards and guidelines from public organizations and standards committees.
建筑物、设施、设备和系统与项目相关设计及安装将遵守美国联邦、欧洲和中国的规范,以及
源于公共机构和标准委员会出版的标准和指导方针。

7.2 The facility architectural layout incorporates an integrated design that satisfies the project
and cGMP requirements, specifications, and addresses identified risk assessment factors,
while providing good levels of access for operation, maintenance, personnel, product,
component, and raw material movements.
该设施建筑布局包含了一个集成的设计,满足了项目和cGMP的需求、规格说明、和标明识
别风险评估因素,同时提供良好的访问级别的操作、维护、人员、产品、零部件和原材料的转
移。

7.3 The *** facility design is divided into five separate classifications/categories:
* * *设施设计分为五个不同类别：
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7.4 Room pressurization for controlled areas shall be designed to include a series of cascading
positive and negative differential pressures for both product protection and maintenance of
cleanliness levels and for containment of cytotoxic and potent compounds. To maintain
pressurization relationships, a door interlock system will be provided at each airlock.
洁净室压力的控制区域的设计要包括一系列级联正压和负压的压差，用于产品的保护和维护清洁水平
和控制的细胞毒性和有效化合物。

为了维持压差的关系，一个互锁门系统将在每个气闸处被应用。

8.0 Validation Approach 验证方法
8.1 Validation Project Methodology 验证项目方法学
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8.2 Risk Based Validation 基于风险验证
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8.3 Change Control 变更控制
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8.4 Continuous Process Monitoring 持续工艺监控
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8.5 Revalidation 再验证
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8.6 Validation Documentation 验证文件
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8.7 Validation Strategies 验证策略
8.7.1 Water Systems 水系统
8.7.2 Clean Steam System 洁净蒸汽系统
8.7.3 Gas Systems 气体系统
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8.7.4 HVAC Systems 空调系统
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8.7.5 Vial Filling Line 西林瓶灌装线
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8.7.6 Cleaning Validation 清洁验证
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8.7.7 Computerized Systems 计算机系统验证
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8.7.8 Process validation 工艺验证
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8.7.9 Analysis method Validation 分析方法验证
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9.0 Attachments 附件
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10.0 Revision History 修订历史
Section No. 版本号Change Description/Rationale 变更表述/原由。