WHO纯化水验证去年发布的一个技术报告

美智越谕

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赤脚天使

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罗伊鲱

这是2012年的WHO文件。来源看更早的FDA 1993年的 GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS。
II. SYSTEM VALIDATION
After all the equipment and piping has been verified as installed correctly and working as specified, the initial phase of the water system validation can begin. During this phase the operational parameters and the cleaning/ sanitization procedures and frequencies will be developed.
Sampling should be daily after each step in the purification process and at each point of use for two to four weeks. The sampling procedure for point of use sampling should reflect how the water is to be drawn e.g. if a hose is usually attached the sample should be taken at the end of the hose. If the SOP calls for the line to be flushed before use of the water from that point, then the sample is taken after the flush. At the end of the two to four week time period the firm should have developed its SOPs for operation of the water system.

The second phase of the system validation is to demonstrate that the system will consistently produce the desired water quality when operated in conformance with the SOPs. The sampling is performed as in the initial phase and for the same time period.  At the end of this phase the data should demonstrate that the system will consistently produce the desired quality of water.

The third phase of validation is designed to demonstrate that when the water system is operated in accordance with the SOPs over a long period of time it will consistently produce water of the desired quality. Any variations in the quality of the feedwater that could affect the operation and ultimately the water quality will be picked up during this phase of the validation. Sampling is performed according to routine procedures and requencies. For Water for Injection systems the samples should be taken daily from a minimum of one point of use, with all points of use tested weekly. The validation of the water system is completed when the firm has a full years worth of data.

lcnlovewez

英文的，看不懂

叶子--

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刘萝莉CC

冰城 发表于 2013-8-19 09:02
不错的资料，学习下。第二阶段是否不用那么频，个取样点每周轮流取一次即可？

我也觉得根据第一阶段的取样测试结果，再判断第二阶段是否需要每天取样比较好；如果结果良好，可以考虑第二阶段的循环取样三次。