取样、测试和监控的要求
33 — predetermined acceptance criteria for drawing conclusions. 用以推导结论的既定合格标准。
9.3 There should be a description of the way in which the results will be analysed. 应说明用以分析结果的方法。
9.4 The protocol should be approved prior to use. Any changes to a pro-tocol should be approved prior to implementation of the change.
在投入使用之前，这些方案应得到批准。如变更了方案，那么，在将这些变更投入使用之前，这些方案的变更也需要获得批准。
10. Quali?cation and validation reports 确认和验证报告
10.1 There should be written reports on the quali?cation and validation performed.
应有已执行的确认和验证活动的书面报告。
10.2 Reports should re?ect the protocols followed and include at least the title and objective of the study; reference to the protocol; details of material, equipment, programmes and cycles used; procedures and test methods.
报告的内容应表明方案已执行，且至少要说明研究的标题和对象、方案的参考资料、使用到的物料、设备、计划和时间的明细、程序及实验方法。
10.3 The results should be evaluated, analysed and compared against the pre-determined acceptance criteria. The results should meet the acceptance criteria; deviations and out-of-limit results should be investigated. If these deviations are accepted, this should be justi?ed. Where necessary further studies should be performed.
要对结果进行评估和分析，并用既定的合格标准与之比较。结果应当符合合格标准，如发现有偏差和超出接受限度的结果，应对之展开调查。如果这些偏差尚在接受范围内，需给出相应证明。需要时，要展开进一步的研究。 10.4 The departments responsible for the quali?cation and validation work should approve the completed report.
完成的报告应得到确认和验证工作的负责部门的批准。
10.5 The conclusion of the report should state whether or not the outcome of the quali?cation and/or validation was considered successful.
报告中给出的结论应阐述了该确认和/或验证工作的结果是否成功。
10.6 The quality assurance department should approve the report after the ?nal review. The criteria for approval should be in accordance with the company’s quality assurance system.
终审之后，报告应得到质量保证部门的批准。审批标准应严格遵循企业的质量保证系统的要求。
10.7 Any deviations found during the validation process should be acted upon and documented as such. Corrective actions may be required.
应按照规定，记录验证过程中发现的所有偏差。需要时，采取相应的纠偏措施。
34 Quali?cation stages 确认程序
11.1 There are four stages of quali?cation: 有四种确认：
35 — design quali? cation (DQ); 设计确认（DQ）
36 — installation quali? cation (IQ); 安装确认（IQ）
37 — operational quali?cation (OQ); and 运行确认（OQ）；以及
38 — performance quali? cation (PQ). 性能确认（PQ）。
11.2 All SOPs for operation, maintenance and calibration should be prepared during quali?cation.
确认工作阶段，应准备操作、维护和校准的SOP。
11.3. Training should be provided to operators and training records should be maintained.
应对操作人员进行培训，并保存培训记录。 Design quali? cation 设计确认
11.4 Design quali?cation should provide documented evidence that the design speci?cations were met.
设计确认的活动应能给出工作对象达到设计标准的文件化证明。 Installation quali? cation 安装确认
11.5 Installation quali?cation should provide documented evidence that the installation was complete and satisfactory.
安装确认的活动应能给出工作对象已正确安装的文件化证明。
11.6 The purchase speci?cations, drawings, manuals, spare parts lists and vendor details should be veri?ed during installation quali? cation.
采购标准、图纸、使用手册、零部件清单和供应商的详细资料都应在安装确认阶段得到确认和核实。
11.7 Control and measuring devices should be calibrated. 应校准控制和测量仪器。 Operational quali? cation 运行确认
11.8 Operational quali?cation should provide documented evidence that utilities, systems or equipment and all its components operate in accor-dance with operational speci? cations.
运行确认的活动应可提供公用工程、系统或设备及其所有部件的运行均符合运行技术标准的文件化证明。
11.9 Tests should be designed to demonstrate satisfactory operation over the normal operating range as well as at the limits of its operating condi-tions (including worst case conditions).
设计此阶段进行的试验时，应确保在正常运行范围及运行条件的上下限值（包括最差状况）的情况下运行时，确认对象都能实现满意的运行结果。 11.10 Operation controls, alarms, switches, displays and other operational components should be tested.
应检测操作控制装置、报警装置、开关、显示屏和其他操作部件。
11.11 Measurements made in accordance with a statistical approach should be fully described.
应充分说明测量活动与统计方法一致。 Performance quali?cation 性能确认
11.12 Performance quali?cation should provide documented evidence that utilities, systems or equipment and all its components can consistently per-form in accordance with the speci?cations under routine use.
性能确认活动应能给出文件证明，说明在常规使用时，公用工程、系统或设备及其所有部件的性能均符合标准，且具备持续性。
11.13 Test results should be collected over a suitable period of time to prove consistency.
为证明结果的持续性，应以适当的时间间隔采集试验结果。 Requali?cation 再确认
11.14 Requali?cation should be done in accordance with a de? ned schedule. The frequency of requali?cation may be determined on the basis of factors such as the analysis of results relating to calibration, veri?cation and maintenance.
应按照事先制订的时间表执行再确认工作。可根据校准相关结果的分析、核实确认和维护等因素确定执行再确认的频率。
11.15 There should be periodic requali?cation, as well as requali? cation after changes (such as changes to utilities, systems, equipment; maintenance work; and movement). (See also point 5.2.5 above and section 12 below.)
应定期开展再确认工作；发生变更后，也应再次进行确认（如公用工程、系统、设备、维护工作和设备/设施的位置变动等变更）。（见下文第12部分及上文的5.2.5）
11.16 Requali?cation should be considered as part of the change control procedure.
应将再确认视为变更控制程序的组成部分。 Revalidation
再验证
11.17 Processes and procedures should be revalidated to ensure that they remain capable of achieving the intended results.
为确保工艺和方法能实现预期效果，应执行再验证。
11.18 There should be periodic revalidation, as well as revalidation after changes. (See also points 5.2.5 above, point 11.21 below and section 12 below.)
应定期执行再验证；变更后，也应再次进行验证。（见上文的5.2.5，下文的11.21和第12部分）
11.19 Revalidation should be done in accordance with a de? ned schedule. 应根据既定的时间表执行再验证。
11.20 The frequency and extent of revalidation should be determined using a risk-based approach together with a review of historical data. 可在风险评估和审查历史数据的基础上，确定再验证的执行频率和执行等级。 Periodic revalidation 定期再验证
11.21 Periodic revalidation should be performed to assess process changes that may occur gradually over a period of time, or because of wear of equipment. 为了评估可能的工艺变更，或设备磨损造成的该变，更应开展定期再验证， 11.22 The following should be considered when periodic revalidation is performed:
执行定期再验证时，应考虑下列问题：
39 — master formulae and speci? cations; 主配方及技术标准 40 — SOPs; SOP
41 — records (e.g. of calibration, maintenance and cleaning); and 记录（如校准、维护和清洁记录）；以及 42 — analytical methods. 分析方法
Revalidation after change 变更后的再验证
11.23 Revalidation should be performed following a change that could have an effect on the process, procedure, quality of the product and/or the product characteristics. Revalidation should be considered as part of the change control procedure.
发生了可能对工艺、方法、产品质量和/或产品特性有所影响的变更后，应当执行再验证。可将再验证视为变更控制程序的组成部分。
11.24 The extent of revalidation will depend on the nature and signi? cance of the change(s).
再验证的执行程度视变更的性质和重要性而定。
11.25 Changes should not adversely affect product quality or process characteristics.
变更不得对产品质量或工艺特性产生不利影响。
11.26 Changes requiring revalidation should be de?ned in the validation plan and may include:
应在验证计划中阐明何种变更要求再验证的执行，这些变更可能包括： 43 changes in starting materials (including physical properties, such as density, viscosity or particle size distribution that may affect the process or product); 起始物料的变更（包括物料的物理性质如密度、黏度或粒径分布等可能对工艺或产品造成影响的变更）；
44 change of starting material manufacturer; 起始物料供应商的变更；
45 transfer of processes to a different site (including change of facilities and installations which in?uence the process); 生产工艺转移到其它地点（包括厂房设施和安装等对工艺有影响的变更）； 46 changes of primary packaging material (e.g. substituting plastic for glass); 内包材的变更（如用玻璃取代塑料）；
47 changes in the manufacturing process (e.g. mixing times or drying temperatures);
生产工艺的变更（如混合时间或干燥温度）；
48 changes in the equipment (e.g. addition of automatic detection systems,
installation of new equipment, major revisions to machinery or apparatus and breakdowns);
设备变更（如自动检测系统的新增、新设备的安装、设备或仪器的重要修改和故障）；
49 production area and support system changes (e.g. rearrangement of areas, or a new water treatment method);
生产区域和支持系统的变更（如区域的重新安排或新的水处理系统的使用）；
50 appearance of negative quality trends; 质量负趋势的出现；
51 appearance of new ?ndings based on current knowledge, e.g. new tech-nology; 在现有知识的基础上，有了新的发现，如新技术； 52 support system changes. 支持系统的变更。
Changes of equipment which involve the replacement of equipment on a ―like-for-like‖ basis would not normally require a revalidation. For exam-ple, installation of a new centrifugal pump to replace an older model would not necessarily require revalidation.
在―相等‖的基础上进行的设备变更，即相同的设备之间发生的替换，通常不需要再验证。例如，用新的离心泵取代同样的旧设备是无需再验证的。