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发表于 2017-9-2 23:51:33
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通常情况下不需要：（后两个引用关于清洁验证，原理是一样的）
The commercial manufacturing process and routine procedures must be followed during PPQ protocol execution (§§ 211.100(b) and 211.110(a)). The PPQ lots should be manufactured under normal conditions by the personnel routinely expected to perform each step of each unit operation in the process. Normal operating conditions should include the utility systems (e.g., air handling and water purification), material, personnel, environment, and manufacturing procedures.
The approach to PPQ should be based on sound science and the manufacturer’s overall level of product and process understanding and demonstrable control. The cumulative data from all relevant studies (e.g., designed experiments; laboratory, pilot, and commercial batches) should be used to establish the manufacturing conditions in the PPQ. To understand the commercial process sufficiently, the manufacturer will need to consider the effects of scale. However, it is not typically necessary to explore the entire operating range at commercial scale if assurance can be provided by process design data. Previous credible experience with sufficiently similar products and processes can also be helpful. In addition, we strongly recommend firms employ objective measures (e.g., statistical metrics) wherever feasible and meaningful to achieve adequate assurance.
FDA process validation
https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf
10.4. Validation should consider the level of automation in the cleaning process. Where an automatic process is used, the specified normal operating range of the utilities and equipment should be validated.
10.5. For all cleaning processes an assessment should be performed to determine the variable factors which influence cleaning effectiveness and performance, e.g. operators, the level of detail in procedures such as rinsing times etc. If variable factors have been identified, the worst case situations should be used as the basis for cleaning validation studies（这个和cleaning validaiton不同，是指前面的process design 阶段）.
EU Annex 15 qualification and validation
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2015-10_annex15.pdf
Section 10.4 appears to be a statement similar to the FDA in its Process Validation guidance related to getting away from “worst case” conditions in a protocol and validating the normal operating range, particularly for automated cleaning processes. The specific statement in 10.4 is “Where an automatic process is used, the specified normal operating range of the utilities and equipment should be validated.” This interpretation, however, should be taken in light of what is stated in 10.5 about “worst case situations”.
Section 10.5 calls for a determination of the “variable factors” in a cleaning process, and if “variable factors have been identified, the worst case situations should be used as the basis for cleaning validation studies.” The cleaning “studies” here could refer to design and development studies done as part of a life cycle approach, but they might also apply to the validation protocols themselves.
What’s in Annex 15
http://101.247.67.17:9011/www.cleaningvalidation.com/c3pr90ntc0td/files/104545746.pdf
图片选自：
https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/implementing-fda-amp-ema-process-validation-guidance.pdf?sfvrsn=6
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