TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划
因我公司本次验证所使用设备均为生产非无菌产品，最终清洁效果应不超出要求最苛刻产品的微生物限度。
7.8.6 Expiry Date of Cleaned Equipment/确定清洁设备的存放有效期
The cleaned equipments should be stored securely and avoided contamination. Swab or rinsing sampling must be carried out after a period of storage to test the biological contamination and confirm the expiry storage period for equipment.
通过对已清洁设备进行存放，存放期间不得污染，存放一定时间后，再按擦拭取样/淋洗取样，检测微生物污染的程度，以确定设备的存放有效期。
7.9
Process Validation/生产工艺验证
The products to be manufactured are transferred from CPL, and the process is unchanged except the equipments and batch size, therefore, the trial production should be conducted for the technical transference to confirm the production parameters on Tripardus equipments. The validation is to testify that the transferred process and operation will be satisfied for the routine production, and that the manufactured products will conform to the specified specifications and with sound reproducibility and reliability.
因我公司产品为CPL生产技术转移，变更了生产设备和生产批量，基本生产工艺不变，所以要对生产技术转移进行试生产，以确定在TRIPARDUS的生产设备中生产的具体参数，验证是证明已经转移和建立的工艺条件、操作等能适合该产品的常规生产，并证明在使用规定的原辅料、设备的条件下，能始终生产出符合预定的质量标准要求的产品，且具有良好的重现性和可靠性。 7.9.1 Preconditions/验证先决条件
——Various validations in the plant have been completed and qualified, staff training has been finished.
车间各项验证工作已完成，并得到批准，人员培训得到确认。
——The specifications of raw materials, intermediate product and finished product have been established and approved. 原辅料、中间产品、成品质量标准必须建立，并得到批准。 ——The test method have been validated and approved. 所用到的检验方法已经验证并批准。 7.9.2 Validation Method/验证方法
Three consecutive batches will be concurrent validated. The storage period of intermediate product needs validating. 采用三批产品的同步验证。中间产品的存放时间需要进行验证。
7.10 Validation of Computerized System/计算机化系统验证
Risk analysis should be undertaken for the validation project, and the irritability validation should be carried out for the computerized system that may affect the quality, mainly include the accuracy of input, output and control, the safety of electronic record, and the authorization of computerized system control.
应经过风险分析确定需要验证的计算机系统，对生产质量可能产生影响的计算机化系统应进行验证，主要是输入输出、控制正确性，有电子记录的计算机化系统应注意电子记录的安全性，人员对计算机化系统控制的权限。可接收标准为符合URS和GMP或GAMP要求，计算机化系统一般由供应商和进行配置的专业IT人员与使用人员共同进行测试，供应商应提供测试服务和资料。
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7.10.1 Hardware/硬件
The function instruction should be stated as the risk assessment, e.g. for the brand computer or server, it is acceptable to state the function instruction of hardware.
范围应进行风险分析，方法是功能说明，如使用品牌电脑或服务器，只要将硬件的功能说明即可。
7.10.2 Operational System/操作系统
For the basic operational system, such as the WINDOWS system, it’s acceptable to state the type and version number.
如果应用的是基本的操作系统，如WINDOWS系统，说明使用的型号和版本号即可。 7.10.3 Firmware/生产或支持设备使用的固件
State the performance and functions, and test whether they meet the requirements. 应说明性能和功能，并进行试验是否能达到要求。 7.10.4 Commercial system/商业化系统
Matured commercial system is applied for the test instruments and office computer, and the type, version number and function should be introduced and the test should be undertaken according to the function introduction.
检验仪器设备与某些需要验证的办公计算机上使用都是成熟的商业化系统，应介绍使用的型号和版本，介绍功能，并按照功能介绍进行试验。 7.10.5 Configurable software package/可配置软件包
ERP system is the configurable software package, and the black-box test should be carried out for in-configurable parts. As for the parts configured by Tripardus, the black-box test should be conducted at least; white-box test and code test can be carried out when necessary.
ERP系统应为可配置软件包，对不可配置部分进行黑箱测试，对我公司自己配置部分，至少应该进行黑箱测试，必要时可进行白箱测试和代码测试。
8
Deviations and change control/偏差处理及变更控制 8.1
Any deviations from the validation should be recorded. The significance of these deviations when assessing the overall success of the Validation exercise must be assessed by the relevant members of the Validation Team, and finally evaluated by the members of Validation Committee. If there is critical deviation from the special test and the test results is ineffective assessed by the members of Validation Committee, the protocol must be revised and validated. 在验证中发现的任何偏差均应记录，偏差对验证结果是否影响，影响多大，应有验证小组进行分析并报告，最后均应经过验证委员会进行最后评估和评价。对于特殊的检测，如果有“重大”偏差，经过验证委员会最后评估检测无效的，验证小组必须修订验证方案重新进行验证试验。 8.2
Any deviations from the validation or USR change need to be treated as follows:
本次验证过程中，发现有的验证项目有偏差，不符合URS需要进行变更或URS本身有变更，应按下列程序处理：
8.2.1 The URS change must be reviewed by Validation Committee.
URS变更应通过验证委员会审核后方可进行。
8.2.2 Other changes should be risk assessed and validated, and the change protocol and validation
protocol must be reviewed by Validation Committee.
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其他变更应对变更内容重新进行风险分析和验证，变更方案以及验证方案均应通过验证委员会审核后进行。
8.3
The SOP on Change Control should be established by QA after finishing writing the VMP, to ensure that the major change that may affect the product quality, safety or efficacy can meet cGMP requirements, and confirm whether the revalidation is needed according to risk assessment.
本次验证总计划所列内容全部完成后，QA应制定《变更控制程序》，以使那些可能影响产品质量、安全性或效能的主要变更符合cGMP要求，并根据风险评估确定是否需要重新验证。
9 History of Change /文件变更及历史 Reason for Change 变更原因 Date 日期 Issue 版本 1 2 10 References/参引 Validation Organization and Implementation, Document No.:SOP05003 《验证的组织实施程序》编号：SOP05003 11 Annex/附录
Format of Validation Certificate/验证证书格式
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