Determining Criticality—Process Parameters and Quality Attributes Part II; Design of Experiments and Data-Driven Criticality
نویسنده
چکیده
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of parameters and less on product testing. Consequently, the means of determining criticality has come under greater scrutiny. The FDA guidance points to a lifecycle approach to process validation (see Figure 1).
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