发布时间 : 星期一 文章欧盟GMP附录15：确认与验证（修订版英文+中文）更新完毕开始阅读
3. 设备、设施、公用工程和系统的确认阶段
3.1. Qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system. The main stages and some suggested criteria (although this depends on individual project circumstances and may be different) which could be included in each stage are indicated below:
3.1. 设备、设施、公用工程或系统的确认活动应当贯穿其用户需求说明书的制定到使用的各个阶段，主要阶段及其要求如下： User requirements specification (URS) 用户需求说明（URS）
3.2. The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.
3.2. 设备、设施、公用工程或系统的说明应当在URS文件和/或功能说明中定义，应考虑质量的关键性因素，并把GMP风险降低到可接受水平。URS应该是整个验证生命周期中的参照。 Design qualification (DQ) 设计确认
3.3. The next element in the qualification of equipment, facilities, utilities, or systems is DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification.
3.3. 确认活动的第二阶段就是设计确认，这里应当用文件证明其符合GMP要求，还应当对用户需求说明中的要求进行确认。
Factory acceptance testing (FAT) /Site acceptance testing (SAT) 工厂验收测试（FAT）/现场验收测试（SAT）
3.4. Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery.
3.4. 如果需要的话，设备（尤其是新型或复杂的设备）在供应商发货前应在其产地被充分的评估。
第 7 页 共32 页
3.5. Prior to installation, equipment should be confirmed to comply with the URS/functional specification at the vendor site, if applicable.
3.5. 如果需要的话，在供应商的现场，设备应在安装之前被确认是否符合URS或功能说明的要求。
3.6. Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation.
3.6. 合适的话，经过评估，文件审核和部分测试可以在FAT时或其他阶段进行，如果能够证明其功能在运输和安装中未受影响，就不需要在IQ/OQ时重复进行已经做过的审核和测试了。
3.7. FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.
3.7. 在药品生产场地收到设备后，可以紧接着做SAT作为FAT的补充。 Installation qualification (IQ) 安装确认（IQ）
3.8. IQ should be performed on equipment, facilities, utilities, or systems. 3.8. 设备、设施、公用工程或系统应进行安装确认。 3.9. IQ should include, but is not limited to the following: 3.9. 安装确认包括但不限于以下内容：
i. Verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications;
i. 对照设计图纸和说明书，对组件、仪表、设备、管道和服务的安装正确性进行确认。
ii. Verification of the correct installation against pre-defined criteria; ii.
按照预先设定的标准对安装正确性进行确认。
iii. Collection and collation of supplier operating and working instructions and maintenance requirements; iii.
收集并核对供应商操作、工作指令和维护要求。
第 8 页 共32 页
iv. Calibration of instrumentation; iv.
仪表校准。
v. Verification of the materials of construction. v.
核对部件的材质。
Operational qualification (OQ) 运行确认（OQ）
3.10. OQ normally follows IQ but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).
3.10. OQ一般紧跟着IQ，但是根据设备的复杂情况，OQ也可以合并在安装/运行方案中执行(IOQ)。
3.11. OQ should include but is not limited to the following: 3.11.
运行确认包括但不限于以下内容：
i. Tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed;
i. 根据工艺、系统和设备的相关知识开展测试，以确保其可以像设计的那样运行。
ii. Tests to confirm upper and lower operating limits, and /or “worst case” conditions. ii.
对其上下操作线或最差工况进行测试。
3.12. The completion of a successful OQ should allow the finalisation of standard operating and cleaning procedures, operator training and preventative maintenance requirements.
3.12. 成功的完成OQ后，就可以进行标准操作规程、清洁规程、员工培训、预防性维护的最终定稿。 Performance qualification (PQ) 性能确认（PQ）
3.13. PQ should normally follow the successful completion of IQ and OQ. However, it may in some cases be appropriate to perform it in conjunction with OQ or Process Validation.
第 9 页 共32 页
3.13. 性能确认一般是在安装确认和运行确认成功完成之后。但是，在有些情况下，也可以将其与运行确认或工艺验证合并进行。 3.14. PQ should include, but is not limited to the following: 3.14.
性能确认包括但不限于以下内容：
i. Tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst case batch sizes. The frequency of sampling used to confirm process control should be justified;
i. 设备使用生产物料、合格替代物或模拟产品在最差批量工况的正常操作条件下进行测试，被证明具有等同表现。工艺控制的取样频次应当经过充分证明。
ii. Tests should cover the operating range of the intended process, unless documented evidence from the development phases confirming the operational ranges is available.
ii. 测试应覆盖预期工艺的操作范围，除非有文件证明在研发阶段确认过操作范围。
4. RE-QUALIFICATION 4. 再确认
4.1. Equipment, facilities, utilities and systems should be evaluated at an appropriate frequency to confirm that they remain in a state of control. 4.1. 应当对设备、设施、公用工程和系统保持合适的评估频率，以确保其依然在受控状态。
4.2. Where re-qualification is necessary and performed at a specific time period, the period should be justified and the criteria for evaluation defined. Furthermore, the possibility of small changes over time should be assessed. 4.2. 如果需要在一个特定时间周期内进行再验证，则应对该时间周期进行论证，并确定评估的标准。此外，应评估随着时间推移产生小变更的可能性。 5. PROCESS VALIDATION 5. 工艺验证 General 通则
第 10 页 共32 页