Figure 7.5 Decision tree for designating parameter criticality. Source: PDA TR60.

Note the definition in (2) above. This is what is referred to as a critical process parameter. If the parameter changes then a CQA will change and the process will be different than allowed for in the criteria. Table 7.4 Shows some examples of CPPs and CQAs.

Table 7.4

Some CPPs and CQAs


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Mar 4, 2017 | Posted by in PHARMACY | Comments Off on Parameters

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