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下面是标准出处
12.2.2Qualification and Monitoring Strategy
The sampling strategy for initial qualification in biotech APl facilities is comparable to that described in Table 11.3.
For routine monitoring purposes in biotech APl facilities, it may be useful to increase the microbial sampling frequencies compared to Table 11.5 as there is a higher perceived risk regarding microbial impurities. Therefore, inthe example, the sampling frequency is changed to monthly for critical use points. Use points with indirect impact are tested quarterly.
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