? 建立和指定检测失败程序
Phase 2. A further test period of two weeks should be spent carrying out further intensive monitoring while deploying all the refined SOPs after the satisfactory completion of phase 1. The sampling scheme should be generally the same as in phase 1. Use of the water for FPP
manufacturing purposes during this phase may be acceptable, provided that both commissioning and phase 1 data demonstrate appropriate water quality and the practice is approved by QA. The approach should also:
第二阶段：在第一阶段圆满完成后，根据所有拟定的SOP再持续两周检测。取样计划一般应与第一阶段的相同。如果调试和第一阶段数据均证明可以获得理想的水质，且经过QA批准，则此阶段的产水可以用于制剂的生产。方法还应
— demonstrate consistent operation within established ranges; — 证明在建立的范围内可以持续进行操作
— demonstrate consistent production and delivery of water of the required quantity and quality
when the system is operated in accordance with the SOPs.
— 证明根据SOP进行操作时，水系统可以生产和输送符合质量标准和要求数量的水 Phase 3. Phase 3 typically runs for one year after the satisfactory completion of phase 2. Water can be used for FFP manufacturing purposes during this phase which has the following objectives: 第三阶段：第三阶段一般在第二阶段满意完成后，再运行一年。在本阶段，水可以用于制剂生产，本阶段验证目的如下：
? to demonstrate reliable performance over an extended period; ? 应在一段较长时间内证明性能稳定性 ? to ensure that seasonal variations are evaluated. ? 应保证对季节性变化进行评估
The sample locations, sampling frequencies and tests should be reduced to the normal routine pattern based on established procedures proven during phases 1 and 2.
基于第一阶段和第二阶段数据，建立常规监控模式，在第三阶段，将取样位置、取样频次和检测降低至常规模式。
7.5.2 For new systems, or systems that display instability or unreliability, the following should also be reviewed: 对于新的系统，或表现不稳定或不可靠的系统，以下内容也应该进行回顾 — need for investigation; — 是否需要调查
— corrective actions and preventative actions (CAPA); — 纠正和预防措施（CAPA）
— qualification (DQ, factory acceptance test (FAT), IQ, site acceptance test (SAT), OQ, PQ) or
equivalent verification documents, and monitoring phases of the system.
— 确认（DQ，工厂接受性检测（FAT），IQ，场所接受性检测（SAT），OQ，PQ）或相
当的确认文件，系统的监控阶段的文件 8. Inspection of water systems 水系统的检查
8.1 WPU (BPW, BHPW and BWFI) systems are likely to be the subject of regulatory inspection from time to time. Users should consider conducting routine audit and self-inspection of established water systems.
WPU（BPW, BHPW和BWFI）系统可能会受到官方不时的检查。用户应考虑对已有的水系统进行常规审计和内部审计。
8.2 This GMP guidance can be used as the basis of inspection. A tour of the water generation plant and visible pipework (including user points) should be performed to ensure that the system is appropriately designed, installed and maintained (e.g. that there are no leaks and that the system matches the piping and instrumentation diagram or drawing (P&ID).
本GMP指南可以用于作为检查的基础。应对制水车间和可见的管道（包括使用点）进行现场视查，以保证系统被适当设计、安装和维护（例如，无泄露，系统与PID图符合） A following list identifies items and a logical sequence for a WPU system inspection or audit: 以下清单列出了WPU系统检查的内容和逻辑顺序
— a current drawing of the water system showing all equipment in the system from the inlet to
the points of use along with sampling points and their designations;
— 水系统的现行图，图中包括所有系统中所有从进口到使用点的设备，以及取样点和其设
计
— approved piping drawings (e.g. orthographic and/or isometric); — 批准的工艺管道图（例如，投影图和/或平面图）
— a sampling and monitoring plan with a drawing of all sample points; — 取样和监控计划，配有所有取样点的分布图 — training programme for sample collection and testing; — 取样和检测培训计划
— the setting of monitoring alert and action levels; — 监控警报设定和行动水平
— monitoring results and evaluation of trends; — 监控结果和对趋势的评估
— inspection of the last annual system review; — 去年年度系统回顾检查
— review of any changes made to the system since the last audit and a check that the change
control has been implemented;
— 检查自上次审计以来对系统所做的所有变更，检查所实施的变更控制 — review of deviations recorded and their investigation; — 检查记录的偏差和对其进行的调查
— general inspection of system for status and condition; — 系统状态和情况的一般检查
— review of maintenance, failure and repair logs; — 检查维保、失效和维修日志
— checking calibration and standardization of critical instruments. — 检查关键部件的校正和校准
8.3 For an established system that is demonstrably under control this scope of review should prove adequate. 对于一个已建立的系统，并证明是受控的情况下，上述检查就充分了。 Further reading
The International Pharmacopoeia. Geneva, World Health
Organization;http://www.who.int/medicines/publications/pharmacopoeia/overview/en/index.html. 国际药典
WHO guidelines on good manufacturing practices: validation. In: WHO Expert Committee on SpeciThcations for Pharmaceutical Preparations. Fortieth report. Geneva, World Health Organization, 2006, Annex 4 (WHO Technical Report Series, No.
937);http://www.who.int/medicines/publications/pharmprep/TRS_937.pdf#page=119. WHO对GMP指南：验证（第937号技术报告附件4）
WHO Guidelines for drinking-water quality, 3rd edition. Geneva, World Health Organization, 2008;http://www.who.int/water_sanitation_health/dwq/gdwq3rev/en/index.html. WHO对饮用水质量的指南，第三版，2008
American Society of Mechanical Engineers. Bioprocessing Equipment Standard. ASME — BPE 2000.
美国机械工程协会，生物处理设备标准，2000
Banes PH. Passivation; understanding and performing procedures on austenitic stainless steel systems. Pharmaceutical Engineering, 1990: 41.
钝化，奥氏铁不锈钢系统的理解和性能程序，药物工程，1990
Guide to inspections of high purity water systems. Maryland, US Food and Drug Administration, 1993;http://www.fda.gov/ICECI/InspectionGuides. FDA对高纯水系统的检查指南，1993
Biotechnology. Equipment. Guidance on testing procedures for cleanability. British Standards Publishing. BS EN 12296, 1998.
生物技术设备，可清洁检测程序指南，英国标准，1998
European Medicines Agency. Note for guidance on the quality of water for pharmaceutical use. London, 2002
(CPMP/QWP/158-01);http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003394.pdf.
欧洲药物管理局，药用水质量指南注释，2002
European Pharmacopoeia: see web site for the publishers of the European Pharmacopoeia and supplements; http://www.pheur.org/. 欧洲药典
Harfst WH. Selecting piping materials for high-purity water systems. Ultra Pure Water, May/June 1994.
高纯水系统管道材质的选择，超纯水，1994
ISPE Good practice guide: commissioning and qualification of pharmaceutical water and steam systems. ISPE Baseline TM Pharmaceutical Engineering Guide, Vol. 4. International Society for Pharmaceutical Engineering, 2007.
ISPE优良规范指南：制药用水和蒸汽系统操作和确认，2007
ISPE Baseline Guide Volume 4: Water and Steam Systems. International Society for Pharmaceutical Engineering, 2001. ISPE基线指南，水和蒸汽系统，2001
Noble PT. Transport considerations for microbial control in piping. Journal of Pharmaceutical Science and Technology, 1994, 48: 76–85.
管道中微生物控制关于运输的考虑，药物科技杂志，1994
Pharmaceutical Inspection Co-operation Scheme. PIC/S; Inspection of utilities; P1 009-1. Geneva, Pharmaceutical Inspection Co-operation Scheme, 2002. PIC/S，设施的检查，PI 009-1，2002
Tverberg JC, Kerber SJ. Effect of nitric acid passivation on the surface composition of
mechanically polished type 316 L sanitary tube. European Journal of Parenteral Sciences, 1998, 3: 117–124.
硝酸钝化对316L卫生管表面组份的影响，欧洲注射科学杂志，1998
US Food and Drug Administration. Guide to inspections of high purity water systems, high purity water systems (7/93),
2009;http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm. FDA高纯水系统检查指南，2009
US Pharmacopeia: Published annually; see http://www.usp.org/.
美国药典
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