TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
6.5.1 6.5.2 6.5.3 6.5.4
First Phase/第一阶段 ........................................................................................... 18 Second phase/第二阶段 ...................................................................................... 19 Third phase/第三阶段 ......................................................................................... 20 Fourth phase第四阶段 ........................................................................................ 20
7 Validation Method and Acceptance Criteria/验证方法和可接受标准 ........................................... 21
7.1 URS/用户需求标准 .................................................................................................................... 21 7.2 Analytical methods validation/分析方法学验证........................................................................ 21 7.3 Facilities Validation/厂房设施、仓库设施的验证 ................................................................... 22
7.3.1 Design Qualification/设计确认 ........................................................................... 22
7.3.2 7.3.3
Installation Qualification/安装确认 .................................................................... 22 Operational Qualification/运行确认 ................................................................... 23
7.4 Validation of Clean Rooms and Air-conditioning System/洁净车间、空调系统的验证 ......... 23 7.4.1 Design Qualification/设计确认 ........................................................................... 23
7.4.2 7.4.3 7.4.4
Installation Qualification/安装确认 .................................................................... 23 Operational Qualification运行确认.................................................................... 24 Performance Qualification/性能确认 .................................................................. 25
7.5 Purified water system validation/纯化水系统验证 .................................................................... 26 7.5.1 Design Qualification/设计确认 ........................................................................... 26
7.5.2 7.5.3 7.5.4
Installation Qualification/安装确认 .................................................................... 26 Operational Qualification/运行确认: .................................................................. 26 Performance Qualification/性能确认 .................................................................. 27
7.6 Compressed air system validation/压缩空气系统验证 .............................................................. 28 7.6.1 Design Qualification/设计确认 ........................................................................... 28
7.6.2 7.6.3 7.6.4
Installation Qualification/安装确认 .................................................................... 28 Operational Qualification/运行确认 ................................................................... 29 Performance Qualification/性能确认 .................................................................. 29
7.7 Instruments and equipments validations/仪器设备验证 ............................................................ 29 7.7.1 Design Qualification/设计确认 ........................................................................... 29
7.7.2 7.7.3 7.7.4
Installation Qualification/安装确认 .................................................................... 30 Operational Qualification/运行确认 ................................................................... 30 Performance Qualification/性能确认 .................................................................. 31
7.8 Equipment cleaning validation/设备清洁验证 ........................................................................... 31 7.8.1 Establishment of cleaning procedure/建立清洁规程 .......................................... 32
7.8.3 7.8.4 7.8.5 7.8.6
Validation of sampling method/验证取样方法 ................................................... 32 Confirmation of Chemical Residue/确定化学残留量 ........................................ 32 Confirmation of microbes residue/确定微生物残留量 ...................................... 32 Expiry Date of Cleaned Equipment/确定清洁设备的存放有效期 .................... 33
7.9 Process Validation/生产工艺验证.............................................................................................. 33 7.9.1 Preconditions/验证先决条件 .............................................................................. 33
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7.9.2 Validation Method/验证方法 .............................................................................. 33
7.10 Validation of Computerized System/计算机化系统验证 .......................................................... 33
7.10.1 Hardware/硬件 .................................................................................................... 34
7.10.2 7.10.3 7.10.4 7.10.5
8
9 10 11
Operational System/操作系统 ............................................................................. 34 Firmware/生产或支持设备使用的固件 ............................................................. 34 Commercial system/商业化系统......................................................................... 34 Configurable software package/可配置软件包................................................... 34
Deviations and change control/偏差处理及变更控制 ...................................................................... 34
History of Change /文件变更及历史 ................................................................................................. 35 References/参引 ................................................................................................................................... 35 Annex/附录........................................................................................................................................... 35
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TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
1 Purpose/目的
This Validation Master Plan (VMP) describes the Validation and Qualification activities that will be undertaken at Tripardus Pharmaceuticals Ltd. at first phase before start-up. It summarizes the company’s Validation intentions, philosophy, policy, project, plan, and approach and acceptance criteria. 本验证总计划（VMP）描述了瑞博德制药有限公司新建的一期工程在启用前应该进行的验证和确认活动，概括地阐述验证目的、原则、方针、项目、计划、方法和可接受标准等。
2 Summary/概述 2.1
Company introduction and summary of fist stage project / 公司及一期工程项目概述
Shandong Tripardus Pharmaceutical Co., Ltd. is located in Jinan Export Processing Zone, and the construction start in 2006. Tripardus undertakes manufacturing of products and Nutritional/Vitamin products on a contractual basis. The annual output of tablet will be *** after completion. The warehouse is *** m2 and the granulation plant is *** m2
瑞博德制药有限公司一期工程位于山东济南出口贸易加工区，于2006年开始建设，本工厂根据与客户的合同，从事药品及营养维生素产品的加工。项目建成后，将达到年产量****的片剂生产量，有仓储系统***平方米，制粒生产车间***，……。 2.2
Scope/验证范围
This plan is to be followed for the validation of plant, purified project, facilities, HVAC, purified water system, compressed air system, production equipment, computerized system, process, cleaning procedures, etc. The validation will prove that the plant meets GMP requirements and is suitable for medicine production.
验证包括本次建设的厂房、净化工程、仓储设施、HVAC系统、纯化水系统、压缩空气系统、生产设备、计算机化系统、加工工艺、清洁程序等，本次验证后，本次建设的项目应符合GMP要求可以生产药品。 2.3
Validation Policy /验证方针
In order to produce the product of right quality, safety and efficacy and ultimately protection of patients, the validation must conform to cGMP and customer requirements. .A planned approach is therefore required in order to progress the work in a structured and controlled manner. Ensure the validation is based on the risk assessment and cGMP-related critical equipment, process, cleaning, facilities, computerized system and supportive system have been validated. The risk assessment is carried out with protocol establishment simultaneously by Validation Team. The scope and extent of Validation activities for an individual project, based on the conclusions and recommendations in the GMP Risk Analysis, and approved by Validation Committee as well as QA Manager. 为使瑞博德能生产出合格、安全和有效的产品，最终能保证用户的健康。验证应符合cGMP和客户的验证要求，验证工作应有计划、有组织、有控制的进行，确保验证建立在风险评估的基础上，确保与cGMP相关的、有主要作用的关键设备、工艺、清洗、设施、计算机系统和支持系统都进行验证。风险分析由验证小组成员负责在制定验证方案时进行，根据GMP风险分析的结果和建议确定的单个项目的验证内容和范围，由包括QA经理在内的验证委员会在审核验证方案时批准。
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3 Validation Organizational Chart and Personnel Responsibilities/验证组织结构及人员职责 3.1
Organizational Chart/组织结构图
3.2
Validation Committee/验证委员会
Technical Director is responsible for the whole validation activities; Validation Manager is responsible for co-coordinating. The Validation Committee is compromised of Technical Director, Validation Manager, Production Director, EHS Manager, Commercial Manager, QA Manager, QC Manager, Production Manager, Warehouse Manager, Equipment Manager, Engineering Manager, and Maintenance Manager. 瑞博德的验证总负责人为技术总监，组织协调人为验证经理，由技术总监、验证经理、生产总监、环境安全健康总监、商务总监、QA经理、QC经理、生产经理、仓库经理、设备经理、维修经理组成验证委员会。 3.3
Validation/Qualification Team/验证小组
A Validation/Qualification team is assembled to guide the individual projects through to completion. The team should be multidisciplinary and will be comprised of personnel with skills to assist the satisfactory completion of Validation and Qualification activities, and the Team Leader should be the people who is familiar with the validation project and is appointed by Validation Manager. The team members are appointed by Team Leader at the time of protocol draft. 验证小组是为完成每个项目验证工作而成立的工作小组，该小组应是多学科的，组长由熟悉本项目验证要求的人员担任，小组成员掌握的技术能协助验证和确认工作的圆满完成。组长一般由验证经理根据实际情况指定，小组成员由验证组长在起草验证方案时根据要求指定。 3.4
Responsibilities/职责：
3.4.1 Responsibilities of Validation Committee/验证委员会职责
Personnel人员 Responsible for: 职责 验证小组（1） Validation Team (1) 验证小组 （2） Validation Team (2) 验证小组 （3） Validation Team (3) 验证小组 （4） Validation Team (4) 验证小组 （…） Validation Team (…) Validation Committee/验证委员会 Validation Manager 验证经理 VD01001
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