发布时间 : 星期五 文章山东2008年验证总计划--山东瑞博德制药有限公司更新完毕开始阅读798c3b83d4d8d15abe234e97
TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
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。
VD01001
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TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
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，旨在证实已验证状态没有发生漂移而进行的验证。关键工艺、设施、设备需要进行定期再验证，发生变更的部分需要进行再验证，法规要求强制执行的再验证。
本次验证总计划中的每项验证报告中应该包括再验证的周期，因本次验证无再验证的内容，就不再说明再验证的方法。
本次验证总计划中的验证内容全部完成后，本次建设项目可投入生产，如果有因为变更发生的再验证，按照《变更控制程序》执行，周期性的再验证在下年度的验证总计划中提出。
6.3 Validation Implementation/验证的实施
The Validation Team should be organized and write the validation protocol according to VMP and SOP “Validation Organization and Implementation” The validation activities should be carried out by Validation Team after the approval. The report should be formed and the certificate will be issued by QA Manager. The documentation should be handed over to QA for filing.
按照《验证的组织实施程序》和本计划，成立验证小组，起草验证方案，验证方案经批准后，由验证小组实施，结束后形成验证报告，经审核合格的验证项目由QA经理发放验证证书，验证小组将所有验证文件整理交QA归档。 6.4
Validation Project Collection/本次验证的项目汇总
VD01001
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TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
6.4.1 Analytical Methods Validation/分析方法学
QC Manager is responsible for the analytical methods validation, including the analytical methods from CPL and new adopted one
本部分验证由QC经理负责，包括CPL向TRIPARDUS进行技术转移中涉及的分析方法和新采用的分析方法。 6.4.2 Facilities/设施
The IQ of facilities should conform to the designed output requirements at the first phase specified in this VMP. The URS should be stated and the P&IDs must be reviewed prior to the IQ protocol writing. Equipment Manager is responsible for the facilities validation. The specific equipments to be validated as follows:
设施的设计确认均应符合本验证总计划中一期工程项目的设计产量要求，在制定每个设施的设计验证方案时应先写明URS，对施工的竣工图纸进行审核。本部分验证由设备经理赵岩负责，具体需要验证的设备如下： No./编号 Name/名称 6.4.3 Instruments and equipments/仪器设备 QC Manager is responsible for the test instruments validation; Equipment Manager is responsible for the other equipments. 本部门中的检验设备由QC经理宋晓燕负责，其他设备由设备经理赵岩负责。 No. 编号 Name 名称 HPLC/高效液相 Autoclave/高压灭菌柜 UV/紫外分光光度计 IR/红外 Quantity 数量 1套 1 1 5 Responsible people 负责人 Anna Song/宋晓燕 Anna Song/宋晓燕 Anna Song/宋晓燕 Anna Song/宋晓燕 Facilities/厂房设施 Warehouse /仓储区域 Clean rooms/洁净车间 HVAC system/HVAC系统 Purified water system/纯化水系统 Compressed air system/压缩空气系统 Quantity/数量 1套 1 1 5 1 VD01001
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TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
Clean Bench/净化操作台 Biological Safety Cabinet 生物安全柜 1 Anna Song/宋晓燕 Anna Song/宋晓燕
6.4.4 Process/工艺 Tablet Press Machine/压片机 Granulation Machine/制粒机 Dryer/干燥器 Coating Machine/包衣机 Mixer/混合器 Oven/烘箱 Rocky Zhao/赵岩 Rocky Zhao/赵岩 Rocky Zhao/赵岩 Rocky Zhao/赵岩 Rocky Zhao/赵岩 Rocky Zhao/赵岩 Production Director is responsible for the process validation. 本部分的验证由生产总监常鸿彦负责。具体项目如下： No.编号 Name/名称 ITAMIN C 60 mg CHEWABLE TABLETS T2842维C咀嚼片（60mg） FOLIC ACID TABLETS RTA 60 T2848叶酸片VC ZINC TABLETS RTA 65 T2850锌片 VITAMIN B COMPLEX TABLETS (RTA 67) T2851复合VB片 VITAMIN C 500 mg CHEWABLE TABLETS (RTA69) T2843VC咀嚼片（500mg） MULTIVITAMIN & IRON TABLETS T2838多维铁片 MULTIVITAMIN TABLETS (RTA 57) T2837多维片 VD01001
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