Usually drying after granulation is continued until the target LOD achieve, as LOD could affect in-process as well as finished product CQA, like tablet hardness, related substance, assay etc. Furthermore, with a set of drying process parameters, if the LOD is not achieved the established value on a particular time point, indiates that something in the process is going wrong. Smilarly, the differential pressure during coating provides an idea regarding process performence, like whether process is running smooth or any blockage.
I am bit confused regarding terminology of these type of parameters. Whether LOD could be considered as critical quality attributes (CQA) or control parameter for process or process indicator. Similarly the differential air pressures could be termed as critical process parameter or control parameter for process or process performance indicator.
Looking forward for your suggestion.
Dear Srimanta,
Critical process parameter (CPP): A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled
to ensure the process produces the desired quality – ICH Q8(R1)
Key process parameter (KPP): An adjustable process parameter (variable) of the process that, when maintained within a narrow range, ensures optimum process performance. A key process parameter does not meaningfully affect critical product quality attributes. Ranges for KPPs are established during process development, and changes to operating ranges will be managed within the Quality System – aMab
Hoping this will be helpful,
Rafik
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