IoT-Enabled Global Process Validation System
In the above Figure 2 , consider Biopharma-A and Biopharma-B who have successfully developed COVID-19 vaccines , their certified process validation systems can be replicated in the “ COVID-19 global process validation system ” under two separate instances . These instances can then be then leveraged by other biopharma / CMOs for scaling-up vaccine production globally to ensure high quality .
ADVANCED PROCESS CONTROL ( APC ) 5 CAPABILITIES IN A PV SYSTEM
A traditional process validation system with Statistical Process Control ( SPC ) capabilities keeps track of all types of activities that take place during manufacturing operations and notifies any process deviations to the quality control team using descriptive analytics .
The Advanced Process Control ( APC ) driven process validation system takes into consideration all the significant parameters influencing drug quality such as raw materials , process parameters , asset parameters , environment parameters etc . It also applies advanced analytics techniques such as diagnostic , predictive and prescriptive analytics to identify quality leakages and their root causes and determines corrective and preventive actions ( CAPA ) and provides real-time process optimization insights for improving manufacturing quality of the current and future production batches .
Fig . 3 : Enhancing traditional PV system to IoT enabled APC capabilities
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