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11.1 Water systems should be appropriately qualified and validated (8). The
scope and extent of qualification should be determined based on risk
assessment. (See also point 3.3. above.) 水系统应适当确认和验证。确认的范围和程度应根据风险评估确定。
11.2 When commissioning work is done, this should be documented. Commissioning is not a replacement for qualification. 调试工作应记录在案。调试不能取代确认。
11.3 In order to demonstrate the reliability and robustness of a system and its performance, a three-phase approach should be used for validation, covering at least one year of operation over different seasons. Tests on the source water (drinking-water) should be included within the validation programme and continued as part of the routine monitoring, and these results should meet specifications. 为了证明系统及其性能的可靠性和稳健性，验证工作应分三个阶段进行，在不同的季节至少运行一年。对原水（饮用水）的检测应纳入验证计划，并作为例行监测的一部分继续进行，检测结果应符合规范要求。 Note: A typical phase 1 to 3 approach for a new system is described below.
When changes are made to existing systems, the phase(s) and length of each
phase, as well as sampling points and frequency of sampling should be based
on documented risk assessment. 注：下文介绍了新系统第 1 至第 3 阶段的典型方法。在对现有系统进行更改时，应根据记录在案的风险评估来确定阶段和每个阶段的长度，以及取样点和取样频率。
Phase 1第一阶段
Phase I should cover a period of at least two weeks.
第一阶段应至少涵盖两周。 Procedures and schedules should cover at least the following activities and
testing approaches: 程序和计划应包括以下活动和检测方法：
■ chemical and microbiological testing in accordance with a defined plan; 根据定义的计划进行化学和微生物检测
■ sample, test and monitoring of the incoming feedwater to verify its quality; 对原水进行取样、检测和监测，以验证其质量
■ sample, test and monitoring after each step in the purification process; 在纯化工艺的每个步骤之后取样、检测和监测
■ sample, test and monitoring at each point of use and at other defined sample points including the end of the distribution loop; 在每个使用点和其他定义的取样点（包括总回水点）取样、检测和监测
■ verification of operating ranges; 确认操作范围
■ operating, cleaning, and maintenance; 运行、清洁和维护
■ sanitizing procedures and operating ranges; 消毒程序和操作范围
■ demonstrate the consistent production and delivery of product water of the required quality and quantity; 证明能够持续生产并提供符合所需质量和数量的水 ■ establishing provisional alert and action levels; and 建立临时警戒和行动限；以及
■ test-failure procedure. 检测失败程序
The system should be monitored intensively for its performance. Water should not be used for product manufacturing during this phase 应密切监测系统的性能。在此阶段，不应将水用于产品生产。 Phase 2第二阶段 Phase 2 should cover at least a further test period of two weeks after the satisfactory completion of Phase 1. The system should be monitored while deploying all the standard operating procedures (SOPs). The sampling programme should be generally the same as in Phase 1. The use of the water for product manufacturing purposes during this phase may be acceptable, provided that Phase 1 and ongoing Phase 2 data demonstrate the appropriate water quality and the practice is approved by QA. 第2阶段应在第1阶段圆满完成后至少再进行两周的测试。应在采用所有标准操作程序 (SOP) 的同时对系统进行监测。取样计划应与第1阶段大致相同。如果第1阶段和正在进行的第2阶段的数据显示水质适当，且该做法已获得质量保证部门的批准，则可接受在此阶段将水用于产品生产目的。 The approach should also:该方法还应： ■ demonstrate consistent system operation within established ranges; and 证明系统在既定范围内稳定运行；以及 ■ demonstrate consistent production and delivery of water of the required quantity and quality when the system is operated in accordance with the SOPs. 证明当系统按照标准操作程序运行时，能够始终如一地生产和输送所需水 量和水质的水。 Phase 3第三阶段
Phase 3 should follow phase 2 ensuring that the duration of Phase I, 2 and
3 cover at least 12 months. The sample locations, sampling frequencies
and tests may be reduced according to a routine plan which should be
based on the established procedures and data from Phase 1 and Phase 2.
Data should be trended, for example, quarterly and a system review should
be undertaken after the completion of Phase 3 as part of the evaluation
of system performance capability. The appropriate action should be taken
where such a need is identified.
第3阶段应紧随第2阶段，确保第1、2 和3 阶段至少持续12个月。采样地点、采样频率可根据例行计划减少抽样地点、抽样频率和检测次数，例行计划应以既定程序和第1阶段和第2阶段的数据为基础。应对数据进行趋势分析，例如每季度一次，并在第3阶段完成后进行系统审查，作为系统性能能力评估的一部分。如发现有此需要，应采取适当行动。 Water can be used during this phase. The data and information obtained
during Phase 3 should demonstrate the reliable performance of the system
over this period of time covering the different seasons. 在这一阶段可以使用水。第3阶段获得的数据和信息应能证明该系统在这段时间内不同季节的可靠性能。
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