设计确认SOP

Design Qualification Doc. No.: QAS1. Purpose目的This SOP provides a procedure for the design qualification in XYZ. This proceduredefines the approach,working structure of design qualification and content ofdesign qualification report.本SOP旨在为XYZ工厂的设计确认工作提供一个标准规程。

明确设计去人的方法、工作结构以及文件内容。

2. Scope范围This procedure applies to all new projects, facilities, equipment and operations which have potential GMP and regulation impact in ANBISON. This includes but not limited to:本规程适用于ANBISON工厂所有对GMP法规符合性有潜在影响的设备、操作等的新的投资项目。

包括但不仅限于以下：·Process equipment/facilities/utilities工艺过程的设备/设施/公共辅助系统·Testing equipment/facilities/utilities检验用设备/设施/公共辅助系统·Computerized systems计算机系统Legacy computerized systems should also follow this design qualification procedure.现有计算机系统，也必须遵循设计审核程序。

The cactivities for computerized system design qualification should also follow SOPVAL022<Computerized System Validation>relevant sections except this SOP.Design Qualification Doc. No.: QAS 关于计算机系统的设计阶段的相关工作，除本SOP的规定外，还应参照VAL022《计算机系统验证》的相关章节执行。

3. Responsibility责任Project leader: Project leader ensures all the opinions of Production, Engineering, EHS, Quality Assurance and Validation are covered during design review process.Ensure all the related documents are available for design review.项目负责人：项目负责人负责保证在设计审核过程中，相应的生产、工程维护、安全环保、质量和验证人员的意见、建议均已被包括涵盖。

保证所有相关文件的及时完成，以供审核。

Validation person:Give training to all the personnel who are possible involved in the design review qualification. Ensure design review qualification is implementedaccording to this procedure. Review and approve DQ report.验证人员负责：对所有可能直接介入DQ 过程的人员进行本规程的培训。

确保DQ 按照本规程进行。

对DQ 报告进行审核及批准。

4. Definitions定义：URS：User Requirement Specification 用户需求标准FS：Function Specification 功能标准DS：Design Specification 设计标准DQ：Design Qualification 设计确认VMP：Validation Master Plan 验证主计划RTM：Requirement Traceability Matrix 需求追踪矩阵ERES：Electronic Record & Electronic Signature 电子记录和电子签名5.Safety Notification安全注意事项N/A 不适用于本规程。

Design Qualification Doc. No.: QAS6. Procedure程序：6.1 Basic principles of Design Qualification设计确认（DQ）的基本原则：Design development is the process that ensures user requirements andGMP/regulatory expectations has been incorporated in the design. Design documents in this process include Functional Specification (FS) and Design Specification (DS).These design documents are basic evidences for design qualifications.在设计中将用户需求与GMP法规要求相结合的过程叫做设计开发。

此阶段产生的设计文件包括功能标准（FS）及设计标准（DS）。

这些设计文件将成为进行设计确认最基本证据。

DQ is a process to complete and document design reviews to demonstrate that all user requirements, regulatory requirements and quality aspects have been fullyconsidered in the design of facility, plant, equipment or services. Consideration and recommendations of related departments should be considered at the early design stage.DQ 就是完成并记录设计审核的过程，以证明在厂房、设施、设备或公共辅助系统的设计中已经对所有的用户需求、法规要求和质量关注进行了全面地考虑。

各相关部门的意见、建议应在提出设计要求之初即被纳入。

The people who are responsible for design qualification must have technicalknowledge, typical engineering system experience and familiar with systemoperating interaction and know the approach of design qualification.DQ 应由具备相应技术知识和工程系统典型问题经验，了解系统的操作联系和掌握设计确认方法的人员进行。

6.2 DQ process (reference appendix 1)DQ流程（参见附录1）6.2.1 When a project is established, such as equipment purchasing, introducingor modifying, project owner will be assigned by department manager.当新的建造、购买、引进或改造项目产生时，应由使用部门的经理为其指定项目负责人。

6.2.2 Project owner should raise change control application for the new project.项目负责人为新的项目填写变更控制申请。

Design Qualification Doc. No.: QAS6.2.3 Project owner should prepare User Requirements Specification (URS) after discussion with the experts from Engineering, Process and Quality department.项目负责人与工程，工艺及质量方面的专家讨论后起草用户需求标准（URS）。

6.2.4 Potential supplier develops the system according to the URS of XYZ.　Provides Functional Specification based on URS, briefly describe thesystem function. Provides the detailed Design Specification (DS).潜在供应商根据XYZ 提供的URS 进行设计开发。

根据URS 提供功能标准（FS），进行简单的功能描述。

提供详细的设计标准（DS）。

6.2.5 Project owner should check the design documents provided by supplieragainst URS and DQ review principle in relevant VMP to verify whetherrequirements can be met or not.项目负责人根据URS、供应商提供的设计文件以及已经在VMP 中预先规定的DQ 审核的原理对设计是否符合于其需求进行审核确认。

6.2.6 Project owner complete the DQ report according to review output.项目负责人根据审核结果完成DQ 报告。

6.2.7 The system should be redesigned to modify the defect if there are any major design defects according to conclusion in DQ report. Design qualification will be done after modification until URS requirements can be satisfied.根据DQ 报告的结论确定是否有重要的设计缺陷。