IoT-Enabled Global Process Validation System
Over the years , Statistical Process Control ( SPC ) 7 has played a crucial role in monitoring , measuring and controlling drug quality during the manufacturing process . However , it is primarily known for averting a few immediate defects , and it lacks the ability to provide predictive and prescriptive insights for continuous process improvement to improve quality and reduce production cycle time .
Fig . 4 : Tablet Formulation Manufacturing with standard SPC
For example , in the above Figure 4 , the standard SPC alerts that are generated during each unit operation may have limited scope for real-time in-process decision making that is required to improve overall quality . Therefore , all applicable IPQC tests are performed by default to determine if the processed output at the end of each unit process will lead to batch acceptance or rejection .
Thus , in order to reduce the need to perform IPQC tests for a poor-quality new batch under production that may eventually get rejected , streaming analytics and predictive analytics capabilities can be leveraged . While streaming analytics are used to provide real-time SPC alerts to identify deviations from the validated process , the predictive analytics that consider data of
IIC Journal of Innovation - 45 -