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
5.31. Ongoing process verification should be conducted under an approved protocol or equivalent documents and a corresponding report should be prepared to document the results obtained. Statistical tools should be used, where appropriate, to support any conclusions with regard to the variability and capability of a given process and ensure a state of control.
5.31. 持续性工艺确认应在应批准的方案或等同文件的指导下进行，同时应当准备一个相应的报告来将获取的结果文件化。如果需要的话，可以使用统计学工具来对既有工艺的变化和性能做出判断，以确保工艺处于受控状态。 5.32. Ongoing process verification should be used throughout the product lifecycle to support the validated status of the product as documented in the Product Quality Review. Incremental changes over time should also be considered and the need for any additional actions, e.g. enhanced sampling, should be assessed.
5.32. 连续工艺确认应在产品生命周期中进行，充分考虑随着时间递增的变化情况，评估采取附加措施的必要性（如增加取样），以证明工艺处在产品质量回顾中所述的验证状态。
6. VERIFICATION OF TRANSPORTATION 6. 运输确认
6.1. Finished medicinal products, investigational medicinal products, bulk product and samples should be transported from manufacturing sites in accordance with the conditions defined in the marketing authorisation, the approved label, product specification file or as justified by the manufacturer. 6.1. 成品药物、临床研究用药、大宗原料药及样品应从生产商按照上市许可规定的条件、批准的标签、质量标准或生产合格证进行发运。
6.2. It is recognised that verification of transportation may be challenging due to the variable factors involved however, transportation routes should be clearly defined. Seasonal and other variations should also be considered during verification of transport
6.2. 由于各种变化性因素，对运输确认进行挑战性试验已成为共识，并且明确运输线路。在运输确认中，应当考虑季节和其他变化因素对运输的影响。 6.3. A risk assessment should be performed to consider the impact of variables in the transportation process other than those conditions which are
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continuously controlled or monitored, e.g. delays during transportation, failure of monitoring devices, topping up liquid nitrogen, product susceptibility and any other relevant factors.
6.3. 应当对运输过程中除了持续受控或监测的条件以外的变量因素的影响进行风险评估，比如：运输延迟、监控设备失效、液氮补充、产品敏感性和其他相关因素。
6.4. Due to the variable conditions expected during transportation, continuous monitoring and recording of any critical environmental conditions to which the product may be subjected should be performed, unless otherwise justified. 6.4. 对于运输过程中已知的环境变化，产品可能面对的任何关键环境因素都应持续受控并记录，否则应说明理由。 7. VALIDATION OF PACKAGING 7. 包装验证
7.1. Variation in equipment processing parameters especially during primary packaging may have a significant impact on the integrity and correct functioning of the pack, e.g. blister strips, sachets and sterile components, therefore primary and secondary packaging equipment for finished and bulk products should be qualified.
7.1. 由于设备参数的变化对基础包装的完整性和正确性有重要影响，比如铝塑条形包装、小袋和无菌部件，因此用于最终产品和中间产品的初级和次级包装设备需要进行确认。
7.2. Qualification of the equipment used for primary packing should be carried out at the minimum and maximum operating ranges defined for the critical process parameters such as temperature, machine speed and sealing pressure or for any other factors.
7.2. 初级包装设备的确认应包含关键工艺参数操作范围的上下限，比如温度、转速、密封压力及其他相关因素。 8. QUALIFICATION OF UTILITIES 8. 公用工程的确认
8.1. The quality of steam, water, air, other gases etc. should be confirmed following installation using the qualification steps described in section 3 above. 8.1. 蒸汽、制药用水、空气及其他气体等，应按照本文第3节所述的步骤进行确
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认。
8.2. The period and extent of qualification should reflect any seasonal variations, if applicable, and the intended use of the utility.
8.2. 如果适用的话，确认的周期和程度应当反映任何季节性变化和公用工程的预期用途。
8.3. A risk assessment should be carried out where there may be direct contact with the product, e.g. heating, ventilation and air-conditioning (HVAC) systems, or indirect contact such as through heat exchangers to mitigate any risks of failure.
8.3. 应当对加热、通风、空调系统等与产品直接接触的介质或换热器等不直接接触产品的介质进行风险评估以降低失败的风险。 9. VALIDATION OF TEST METHODS 9. 检验方法验证
9.1. All analytical test methods used in qualification, validation or cleaning exercises should be validated with an appropriate detection and quantification limit, where necessary, as defined in Chapter 6 of the EudraLex, Volume 4, Part I.
9.1. 用于确认、验证或清洁活动中的任何检验方法应当按照第四卷第一部分第六章规定进行包括检测限和定量限在内的分析方法验证。
9.2. Where microbial testing of product is carried out, the method should be validated to confirm that the product does not influence the recovery of microorganisms.
9.2. 如果产品需要做微生物测试，那么检验方法需要进行验证以确保产品不会影响微生物的回收率。
9.3. Where microbial testing of surfaces in clean rooms is carried out, validation should be performed on the test method to confirm that sanitising agents do not influence the recovery of microorganisms.
9.3. 当洁净区做表面微生物检测时，检验方法需要进行验证以确保消毒剂不会影响微生物回收率。
10. CLEANING VALIDATION 10. 清洁验证
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10.1. Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment. Simulating agents may be used with appropriate scientific justification. Where similar types of equipment are grouped together, a justification of the specific equipment selected for cleaning validation is expected.
10.1. 清洁验证的目的是为了确认清洁程序对产品接触设备的清洁效果。根据科学合理的评判，可以使用模拟试剂。如果相同类型的设备作为一组进行验证时，应当说明选择特定设备开展清洁验证的原因。
10.2. A visual check for cleanliness is an important part of the acceptance criteria for cleaning validation. It is not generally acceptable for this criterion alone to be used. Repeated cleaning and retesting until acceptable residue results are obtained is not considered an acceptable approach.
10.2. 清洁验证中的目测检查干净与否是可接受标准的重要评判指标，但只进行目检的话则是不充分的，一般不被接受。重复清洁和重复测试至残留物达到合格标准也被认为是不能接受的。
10.3. It is recognised that a cleaning validation programme may take some time to complete and validation with verification after each batch may be required for some products, e.g. investigational medicinal products. There should be sufficient data from the verification to support a conclusion that the equipment is clean and available for further use.
10.3. 完成一个清洁验证程序需要一定的时间是取得共识的，可能部分产品（如临床试验用产品）在每批生产结束后需要对验证进行确认。应从确认中获得足够的数据以支持“设备已被清洁干净并且满足后续使用”的结论。
10.4. Validation should consider the level of automation in the cleaning process. Where an automatic process is used, the specified normal operating range of the utilities and equipment should be validated.
10.4. 清洁验证应考虑清洁程序的自动化应用水平，当采用自动化程序时，应当验证公用系统和设备指明的正常操作范围。
10.5. For all cleaning processes an assessment should be performed to determine the variable factors which influence cleaning effectiveness and performance, e.g. operators, the level of detail in procedures such as rinsing times etc. If variable factors have been identified, the worst case situations should be used as the basis for cleaning validation studies.
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