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山东2008年验证总计划--山东瑞博德制药有限公司

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山东2008年验证总计划--山东瑞博德制药有限公司 TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划 980 SHANDONG TRIPARDUS PHARMACEUTICALS CO., LTD. 山东瑞博德制药有限公司 VALIDATION DOCUMENT 验证文件 Validation Master Plan for the First Phase 2008年验证总计划 Document No./ 文件编号: VD01001 Issue No./版本号: 1 Issue Date/颁发日期: ...
山东2008年验证总计划--山东瑞博德制药有限公司
TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划 980 SHANDONG TRIPARDUS PHARMACEUTICALS CO., LTD. 山东瑞博德制药有限公司 VALIDATION DOCUMENT 验证文件 Validation Master Plan for the First Phase 2008年验证总计划 Document No./ 文件编号: VD01001 Issue No./版本号: 1 Issue Date/颁发日期: 2007年 12月 28日 Written by/起草人: Tony Liu/刘福堂 Validation Manager /验证经理 Signed/签名: Date/日期: 年 月 日 Authorized by/授权人: Ray Yu/于瑞清 Technical Director/技术总监 Signed/签名: Date/日期: 年 月 日 Document check/审核 Audited by审核人 Title职位 Signature签名 Date日期 Jane Chang/常鸿雁 Production Director/生产总监 Production Manager/生产经理 Tony Liu/刘福堂 QA Manager/QA经理 Rocky Zhao/赵岩 Equipment Manager/设备经理 Anna Song/宋晓燕 QC Manager /QC经理 Engineering Manager/维修经理 Storage Manager/仓库经理 Long Bao/包龙 Commercial Director/商务总监 Distribution QA Validation archive (Completed original) QA验证档案(完整的原件) Technical Director (Copy) 技术总监(复印件) Engineering Manager (Copy) 维修经理(复印件) QC Manager (Copy) QC经理(复印件) Production Manager (Copy) 生产经理(复印件) QA Manager (Copy) QA经理(复印件) Packing Manager (Copy) 包装经理(复印件) Validation Manager (Copy) 验证经理(复印件) Commercial Manager (Copy) 商务经理(复印件) Production Director (Copy) 生产总监(复印件) Table of Content/目 录 61 Purpose/目的 62 Summary/概述 62.1 Company introduction and summary of fist stage project / 公司及一期工程项目概述 62.2 Scope/验证范围 62.3 Validation Policy /验证方针 73 Validation Organizational Chart and Personnel Responsibilities/验证组织结构及人员 73.1 Organizational Chart/组织结构图 73.2 Validation Committee/验证委员会 73.3 Validation/Qualification Team/验证小组 73.4 Responsibilities/职责: 73.4.1 Responsibilities of Validation Committee/验证委员会职责 83.4.2 Responsibilities of Validation Team/验证小组职责: 93.4.3 All Departmental Managers/所有部门经理职责 93.5 Training /验证培训 94 The Writing and Approval of Validation Plan, Protocol and Report/验证计划、方案、的起草审批程序 95 Documentation/文件 95.1 Content/文件范围 95.1.1 Validation Plan/验证计划 105.1.2 Validation Protocol/验证方案 105.1.3 Validation Report/验证报告 105.1.4 Validation Certificate/验证证书 105.2 Format/文件格式 125.3 Validation Document numbering/验证文件的编号 125.4 Validation/Qualification Archiving验证/确认归档 126 Validation Implementation/验证实施 126.1 Safety and Health/安全与健康 126.2 Validation Classification and Applicable Scope / 本次验证所用到的验证分类与适用范围 126.2.1 Prospective Validation / 前验证 136.2.2 Concurrent Validation/同步验证 136.2.3 Revalidation/再验证 146.3 Validation Implementation/验证的实施 146.4 Validation Project Collection/本次验证的项目汇总 146.4.1 Analytical Methods Validation/分析方法学 146.4.2 Facilities/设施 156.4.3 Instruments and equipments/仪器设备 156.4.4 Process/工艺 166.4.5 Equipment Cleaning/设备清洁 176.4.6 Computerized system/计算机化系统 176.5 Schedule/本次验证的时间计划安排 176.5.1 First Phase/第一阶段 186.5.2 Second phase/第二阶段 196.5.3 Third phase/第三阶段 206.5.4 Fourth phase第四阶段 207 Validation Method and Acceptance Criteria/验证方法和可接受 207.1 URS/用户需求标准 217.2 Analytical methods validation/分析方法学验证 217.3 Facilities Validation/厂房设施、仓库设施的验证 217.3.1 Design Qualification/确认 227.3.2 Installation Qualification/安装确认 227.3.3 Operational Qualification/运行确认 227.4 Validation of Clean Rooms and Air-conditioning System/洁净车间、空调系统的验证 237.4.1 Design Qualification/设计确认 237.4.2 Installation Qualification/安装确认 247.4.3 Operational Qualification运行确认 257.4.4 Performance Qualification/性能确认 257.5 Purified water system validation/纯化水系统验证 257.5.1 Design Qualification/设计确认 267.5.2 Installation Qualification/安装确认 267.5.3 Operational Qualification/运行确认: 277.5.4 Performance Qualification/性能确认 287.6 Compressed air system validation/压缩空气系统验证 287.6.1 Design Qualification/设计确认 287.6.2 Installation Qualification/安装确认 297.6.3 Operational Qualification/运行确认 297.6.4 Performance Qualification/性能确认 297.7 Instruments and equipments validations/仪器设备验证 297.7.1 Design Qualification/设计确认 307.7.2 Installation Qualification/安装确认 307.7.3 Operational Qualification/运行确认 317.7.4 Performance Qualification/性能确认 327.8 Equipment cleaning validation/设备清洁验证 327.8.1 Establishment of cleaning procedure/建立清洁规程 327.8.3 Validation of sampling method/验证取样方法 327.8.4 Confirmation of Chemical Residue/确定化学残留量 337.8.5 Confirmation of microbes residue/确定微生物残留量 337.8.6 Expiry Date of Cleaned Equipment/确定清洁设备的存放有效期 337.9 Process Validation/生产工艺验证 337.9.1 Preconditions/验证先决条件 337.9.2 Validation Method/验证方法 347.10 Validation of Computerized System/计算机化系统验证 347.10.1 Hardware/硬件 347.10.2 Operational System/操作系统 347.10.3 Firmware/生产或支持设备使用的固件 347.10.4 Commercial system/商业化系统 347.10.5 Configurable software package/可配置软件包 348 Deviations and change control/偏差处理及变更控制 359 History of Change /文件变更及历史 3510 References/参引 3511 Annex/附录 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,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。 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 Tripardus Pharmaceuticals Senior Management 瑞博德高层 Ensuring that sufficient commitment and resources are available to relevant departments to achieve the aims of the projects set out in the VMP and in compliance with cGMP. 确保为相关部门提供足够的义务和资源,以达到VMP中规定的验证目标,并符合GMP要求。 Validation Manager 验证经理 To co-ordinate validation and qualification projects, draft the VMP, ensure the Validation Team completing the validation, and establish validation archive. 协调验证和确认工作,起草验证总计划,督促各验证小组按照计划和方案完成验证,建立验证档案。 Technical Director 技术总监 To approve the Validation Plan, Validation Protocol and Validation Report 批准验证计划、验证方案、验证报告。 Other members in the Validation Committee 验证委员会其他成员 Ensuring that products are manufactured using Validated Equipment, Facilities, Processes, Test Method and Systems To check the Validation Plan, Protocol and Report. 确保正式生产使用的设施、设备、工艺、检验方法和系统经过验证。 审核验证计划、方案和报告。 QA Manager QA经理 Ensuring that all Validation & Qualification activities are completed and authorized according to QA acceptable standards and in compliance with cGMP. To issue the Validation Certificate for the qualified validation project by referring to the approved Validation Report. Check the Validation Plan, Protocol and Report. 确保按照QA合格标准及GMP要求完成所有的验证和确认。 根据批准的验证报告发放验证合格证书。 审核验证计划、方案和报告。 3.4.2 Responsibilities of Validation Team/验证小组职责: Personnel/人员 Responsibilities/职责 Team Leader 验证组长 To draft the Validation Protocol and Report, organize the individual validation activities, arrange the validation archive, organize the training and ensure the Team Member can keep the record in detail according to the protocol requirements. 起草验证方案、组织项目的具体验证、督促验证小组成员按照验证方案的要求做好验证记录、起草验证报告、整理验证档案,组织相关的验证培训。 Members of Validation Team 验证小组成员 To carry out the validation activities, make record, report the incident, and assist drafting the validation protocol and report. 按照方案实施验证、并做好记录、例外情况及时汇报和记录、协助起草验证方案和报告。 3.4.3 All Departmental Managers/所有部门经理职责 Completion of Validation/Qualification projects relating to their areas. 完成与其区域相关的验证/确认工作。 3.5 Training /验证培训 Appropriate training must be given to facilitate the satisfactory performance of Validation and Qualification activities, including the Validation Plan, Validation Protocol and required skills. The training should follow the requirements specified in “Training Management” 验证过程中,验证计划、验证方案以及验证中应该掌握的技能应该进行培训,培训应遵循《培训管理办法》。 4 The Writing and Approval of Validation Plan, Protocol and Report/验证计划、方案、报告的起草审批程序 4.1 The Validation Plan is written by Validation Manager, Validation Protocol and Validation Report are written by Validation Team Member. 验证计划由验证经理起草,验证方案和报告由验证小组组织起草。 4.2 The documents are checked by all members of Validation Committee. 以上文件的审核由验证委员会全体成员审核。 4.3 The Validation Plan, Protocol and Report are approved by Technical Director. 所有验证计划、方案、报告均由技术总监批准。 4.4 The Validation Certificate is issued by QA Manager by referring to the Validation Report which will state the approved project. 验证报告显示验证符合要求的验证项目由QA经理发放验证证书。 5 Documentation/文件 5.1 Content/文件范围 The documentation is compromised of Validation Plan, Validation Protocol, Validation Report and Validation Certificate 文件包括验证计划、方案、报告、证书 5.1.1 Validation Plan/验证计划 It consists of Validation Master Plan, Individual Validation Plan and Annual Validation Plan, which describe the plan and requirements for individual or annual validation activities. A Validation Plan generally includes the project summary, validation scope, regulatory and statutory requirements, validated project, validation organizational chart, acceptance criteria, documentation requirements and schedule, etc. 包括验证总计划、分项的或年度的验证计划,是对某个项目或者某个年度的验证工作的规划和要求。一般包括:项目概述、验证的范围、所遵循的法规标准,被验证的厂房设施、系统、生产工艺,验证的组织机构,验证合格的标准,验证文件管理要求,验证大体进度计划等内容。 5.1.2 Validation Protocol/验证方案 It is a written protocol stating how to validate and specifying the acceptance criteria. The Validation Protocol generally includes three main parts: the validation project summary which describes the specific contents to be checked calibrated and tested; the acceptance criteria and validation method for critical points; and record, i.e. check and test results and evaluation. 一个阐述如何进行验证并确定验证合格标准的书面方案。通常由三大部份组成:一是验证项目概述,阐述需要检查、校正及试验的具体内容;二是对需要验证的关键点设定可接受标准和验证方法,即检查及试验达到什么要求以及如何检查的方法;三是记录格式,即检查及试验应记录的内容、结果及评估意见。 5.1.3 Validation Report/验证报告 It is a written document for review and evaluation of validation results, miss out and deviations. The contents that are identical with that in the protocol may not be repeated but must be referred to. 对验证方案及已完成验证试验的结果、漏项及发生的偏差等进行回顾、审核并做出评估的说明文件,与方案的内容一致的可以不重复方案内容,仅写明与对应的方案相同即可。 5.1.4 Validation Certificate/验证证书 The Validation Certificate is issued by QA proving the validated project is qualified and maintained in Validation File. The Certificate should indicate the numbers of validation protocol and report, and the applicable scope. 由QA部门颁发一个证书,以证明对某个项目通过验证,存放于项目的档案中。验证证书应包括验证方案和验证报告的编号,以及可以该项目可以使用的范围。 5.2 Format/文件格式 5.2.1 The protocol and report shall typically include, but not be limited to, the following: - 方案和报告一般应包括,但不限于以下内容: 1 Document title, reference and version number, the protocol number should be included in the report 文件题目、文件编号及版本号,报告中应有对应的方案编号 2 Table of Contents, number of document pages, e.g., “Page X of Y” 目录、文件页码,如:第X页共Y页 3 Document personnel endorsement for writing, review and authorization. 文件签字,包括起草、审核和授权 4 Document distribution 文件分发的对象 5 Summary of validation project 验证项目的基本情况概述 6 Summary of individual critical validation project, acceptance criteria and validation method. 每个关键验证项目的简述,确认及合格标准,验证方法 7 Schedule 验证实施的时间计划安排 8 References to other relevant documents applicable to the project (e.g., SOP’s, guidance documents etc.) 适用于本项目的其它相关文件的参引(如SOP、指导文件等) 9 Deviations from the protocol, including the treatment and record. 偏差的处理方案,报告中应有每个偏差的处理情况总结与记录。 10 Validation report, the summary of each validation project including the conclusions, confirmation and suggestions. 报告是对每一个验证关键点的总结,包括结论、确认和建议。 11 Document change history/Reason for update 文件变更历史/修订原因 12 Attachments or appendices, e.g. containing raw data and other supportive information, etc. Adequate cross-reference shall be made in the documentation to information that is not possible to store in the document appendices 附录,如包括的原始数据及其它支持性信息等。无法存放在文件附录中的文件,要有足够的参引。 5.2.2 A pro-forma protocol/report may be used for the simple project. For this format, the test data is filled directly onto the protocol, whereupon the completed protocol becomes the report. This VMP may be used as a model template document on which to base Validation Protocols and Reports. 对一些特别简单的验证项目,可使用一个形式方案/报告。对此,直接将检测数据填在方案中,填写完整的方案,由此形成报告。 本VMP可以作为一个模版文件,建立验证方案和报告。 5.2.3 Validation Record / 验证记录: It is used for recording the results of experiment, calibration and test during the validation process. The format can copy from daily used record or be specifically designed in the protocol. The record can be put in the appendix or in the protocol according to 5.2.2. 验证记录是在验证过程中的实验、校验以及检查的记录,格式可以是日常的记录格式,也可以是在方案中为了此验证而专门设计的记录格式,具体的记录格式可以在附录中,也可以按照5.2.2在方案。 5.2.4 Validation Certificate/验证证书: The Certificate is in A4 size and includes the validation project name, validation protocol number, validation report number, authorizer signature, etc. 验证证书的格式为一张A4纸制作的证书,应该有验证项目的名称、验证方案编号、验证报告编号、授权人签字等。 5.3 Validation Document numbering/验证文件的编号 The document number is assigned by Validation Manager in accordance with SOP “Document Classification and Numbering”. 验证文件的编号按照SOP《文件的分类和编号》由验证经理指定。 5.4 Validation/Qualification Archiving验证/确认归档 All documentation should be managed by Validation Team Leader after the completion and shall be stored in a secure location by QA Document Controller and available for audit review. The Protocol & Validation/Qualification Report should be archived for a minimum of 15 years. Validation Manager is responsible for establishing the validation documentation index. The record should be maintained with validation report as the appendix. 所有文件都应该在验证结束后,由验证小组组长负责整理,将所有验证文件的原件交负责存档的QA存放在一个安全的地方,可随时进行审核,方案和验证/确认报告必须至少存放15年,验证经理应建立并保存所有验证档案的索引。 验证过程的记录作为验证报告的附属档案与验证报告一起保存。 6 Validation Implementation/验证实施 6.1 Safety and Health/安全与健康 No Validation or Qualification activities should be carried out prior to safety checks on equipment being carried out. These checks must be documented and satisfactory. All appropriate Company Health & Safety precautions and policies must be followed when carrying out Validation or Qualification work. 对设备安全检查之前,不能进行验证或确认。这些检查必须归档,并且检查合格。验证或确认时,必须遵循相应的公司安全和健康预防措施及原则。 6.2 Validation Classification and Applicable Scope / 本次验证所用到的验证分类与适用范围 6.2.1 Prospective Validation / 前验证 Validation conducted prior to the formal use of process, procedure, system, equipment or materials, etc. in accordance with the pre-established protocol. The purpose of prospective validation is to testify and confirm the reproducibility and reliability of a process or procedure, which will require comparatively adequate and complete design and development information for the equipment, product or process. The prospective validation is applied for the new product, equipment and process. The success of prospective validation is the essential element for the transference of new process or equipment from research and trial stage to routine production. The approved process and equipments are the initial conditions for starting the routine production. Prospective validation is applied for all the facilities, equipments, test method, computerized system, cleaning method specified in this VMP. 指一项工艺、过程、系统、设备或材料等在正式投入使用前进行的,按照预定验证方案进行的验证。前验证是考察并确认工艺或过程的重现性和可靠性,一般需要有比较充份和完整的设备、产品和工艺的设计开发资料。引入新产品、新设备以及新的生产工艺时应用前验证的方式,前验证的成功是实现新工艺、新设备从研究、试车阶段向生产阶段转移的必要条件,工艺或设备是交付常规生产的起点。 适用于本次验证总计划中所有的设施、设备、检验方法、计算机化系统、清洁方法的验证。 6.2.2 Concurrent Validation/同步验证 Validation conducted simultaneously with the process operation, i.e. a series of activities carried out when data obtained from the process running, to prove that a process meet the expected requirements. The concurrent validation is in fact the trial production under special monitoring conditions to obtain the qualified product and validation results at one time, i.e. the evidence of process reproducibility and reliability, thus will prove the control of process conform to the designed specifications. Concurrent validation is applied to the process validation specified in this VMP. All the products have been manufactured in CPL for many years; the process is stable and directly transferred to Tripardus. 指生产中在某项工艺运行的同时进行的验证,即从工艺实际运行过程中获得的数据作为验证文件的依据,以证明某项工艺达到预定要求的一系列活动。同步验证实际上是特殊监控条件下的试生产,于此既可获得合格产品又可得到验证结果,即“工艺的重现性及可靠性”的证据,从而证实工艺条件的控制达到预计要求。 适用于本次验证总计划中的工艺验证,因为本次计划投产的所有产品均为CPL多年生产的产品,产品工艺稳定,并将原工艺的技术交接给了tripardus。 6.2.3 Revalidation/再验证 Validation conducted for a process, procedure, system, equipment or material after a period of time of validation and use, to prove that the validated status is not changed. Revalidation is required for critical process, facilities, equipments, and whenever there is change and regulatory or statutory requirements. Any projects can not be used for routine production until the completion of all validated contents specified in the VMP. The revalidation resulted from change should be carried out in accordance with SOP “Change Control”. The periodical revalidation is raised in the annual VMP. 指一项工艺、过程、系统、设备或材料等经过验证并在使用一个阶段以后进行的
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