IoT-Enabled Global Process Validation System
While quality prediction ensures that the low quality batches are discarded in advance reducing batch cycle time , the ultimate benefit of advanced analytics lies in not only predicting if IPQC tests will be leading to a batch acceptance or rejection but also prescribing optimum control settings for the subsequent unit operation ’ s process parameters , asset parameters and ambient parameters within the validated state such that adjusting these parameter values will result in favorable IPQC tests ensuring overall batch acceptance .
This can be achieved by leveraging APC capabilities which is a combination of : 1 . Real-time SPC alerts for validated process compliance ; 2 . IPQC prediction for predicting batch quality ; 3 . Prescriptive process optimization for improving quality .
Fig . 6 : Tablet Formulation Manufacturing with APC - streaming , predictive and prescriptive analytics
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