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1、Doc. No./编号: SOP01801/04Page /页码: 1 of 21This SOP is strictly confidential. Any use and copy unauthorized by Pharma is forbidden. 仅限药业有限公司内部使用。未经授权，不得使用或拷贝。Validation Organization and Implementation验证的组织和实施验证的组织和实施Distribution List: 分发清单：QA、QC、PD 生产部、Lo.物控部、TD 技术部、EN 工程部、EQ 设备部 Role 责任人Draft 起草人Revi
2、ew 审核人Review 审核人Review 审核人Review 审核人Review 审核人Review 审核人Approve 批准人 Dept. 部门QAQCPDLo.TDENEQQDName 姓名 Signature 签名 Date 日期QA质量保证部Year/年Month/月Day/日Valid Since 生效日期：Dept. 部门：Approve/批准人：Doc. No./编号：SOP01801/04Validation Organization and Implementation 验证的组织和实施验证的组织和实施Date/日期：Page/页码： 2 of 211Objective
3、 目的目的 Validation organization and system are introduced, and responsibilities for validation is defined in this SOP to ensure that the implementation of validation is systematize and standardized and meet the requirements of Chinese and foreign GMP. 该规程介绍了本公司的验证组织机构，规定了各部门在验证中的职责；描述了验证文件 体系，以确保验证工作系
4、统化、规范化及符合国内外GMP的要求。2Scope 范围范围 This SOP applies to all validation/qualification activities relevant to cGMP: 该程序适用于本公司工厂 GMP 相关的验证活动： Premise and Equipments 厂房和设施 Utilities system 公用系统 Equipment Qualification 设备验证 Analytical Method Validation 检验方法验证 Process and Packaging 工艺与包装 Cleaning Validation 清洁
5、验证 Related Computerized Systems Validation 相关的计算机系统验证 3Responsibilities 职责职责 3.1QA is responsible for drafting, revising, training, implementing and supervising this SOP. QA 负责本规程的起草、修订、培训、执行及监督。 3.2This SOP should be reviewed by the heads of relevant departments and approved by Quality Director. 相关
6、部门负责人审核本规程 ，质量总监负责批准本规程。 3.3This SOP should be correctly understood and carried out by all the relevant personnel of all departments. 所有部门相关人员应充分理解本规程，并按此执行。4Definition 定义定义 4.1Change any planned change against approved protocol that may affect validation or qualification purpose. 变更任何与已批准的验证方案不一致的有
7、计划的改变，这些改变可能会影响最初的验 证目标。 4.2Re-qualification: the qualification on a production process, a system, a equipment or a kind of starting material which has already been qualified, and the re-qualification is carried out at certain time period after putting use, aim to prove that there is no drift to the
8、 “Qualified Status”. 再验证指一项生产工艺、一个系统、设备或者一种原材料经过验证并在使用一个阶段 后，旨在证实其“验证状态”没有发生漂移而进行的验证。 4.3Annual validation item plan: The validation items planned to do the next year,it should be list at the end of each year. 年度验证项目计划：下一年度计划进行的验证项目，每年末对下一年的计划进行列表。Approve/批准人：Doc. No./编号：SOP01801/04Validation Organi
9、zation and Implementation 验证的组织和实施验证的组织和实施Date/日期：Page/页码： 3 of 215Procedures 程序程序5.1Involved departments, personnel and responsibilities 验证相关部门、人员及责任 Validation study is cross-function work. It is a close joint effort of all relative departments on document drafting, review, approval, implementatio
10、n and result assessment. 验证首先是一个跨部门的工作，从验证文件的起草、审核、批准到验证实施及结果评价， 需要各部门的密切合作才能有效实施。 5.1.1Quality Assurance Dept. QA部 Establish and revise validation management procedures of harma, as well as Validation Master Plan. 起草及升版本公司验证管理程序，包括验证主计划； Prepare and implement the annual validation item schedule and
11、 participate in the training. 年度验证项目计划的编制并参与验证培训工作； Draft and direct for drafting the protocol and report of validation/qualification, review and approve for the protocol, change, deviation and report of validation. 起草或指导起草、审核验证方案及报告，参与验证方案、变更、偏差及报告的审核与批 准； Participate or guide validation implementa
12、tion, and result evaluation. 参与及指导验证的实施、结果评价； Supervise problems handling in validation(deviation handling, planned change, time confliction etc.) 监督验证工作中存在问题（如偏差处理，变更，时间冲突等）的解决。 Annual assessment on validation to support VMP revision. 对验证活动的实施情况进行定期汇总及评审，为验证主计划的修订提供依据。 Qualification and validation
13、document management. 验证文件的管理。 5.1.2Quality Control Dept. QC部 Responsible for establishment of analytical method validation SOP; 负责检验方法验证管理程序的建立；Responsible for implementation of QC laboratory equipment/instrument qualification (Include their computerized control system) and analytical method validat
14、ion; such as drafting protocol and report, data record and collection, involve deviation investigation and change management, etc. 负责实验室设备(包括其控制系统)及检测方法验证的具体实施。如方案及报告的起草， 验证中的数据收集与记录，参与偏差调查，变更审核等； Review process validation, cleaning validation and utilities validation document; Participate in valida
15、tion relative analysis drafting , reviewing and implementation ; 审核工艺验证、清洁验证及公用系统性能确认等验证文件；参与所有验证中关于分析检 测内容的起草、审核和实施。 Participate in validation item schedule establishment and implementation. 参与年度验证项目计划的建立及实施。Approve/批准人：Doc. No./编号：SOP01801/04Validation Organization and Implementation 验证的组织和实施验证的组织
16、和实施Date/日期：Page/页码： 4 of 215.1.3Technology Dept. 技术部 Responsible for protocol and report of Technology Depts equipment qualification., , method validation and cleaning validation of transferred products. Responsible for the job of first stage of process validation, including process design, process optimization and so on. 负责本部门设备验证，转移产品相关的方法验证及清洁验证方案及报告的起草；负责公 司产品工艺验证第一阶段即工艺设计阶段的所有工作，包括工艺设计、工艺优化等； Participa
