IoT-Enabled Global Process Validation System
Stage 3 , the Continued Process Verification ( CPV ) of process validation system plays the most important role in ensuring drug quality in a commercial scale production as it leverages statistical measures to determine process performance which in turn determines the batch quality .
Its in-built statistical process control ( SPC ) capabilities leverage data collected from manufacturing execution system ( MES ) ( or ) supervisory control and data acquisition ( SCADA ) and distributed control systems ( DCS ) that are connected to the manufacturing equipment for monitoring and minimizing deviations from the validated process . However , the scope of such a process verification system is limited to basic statistical process control charts of the batch data which lack the capability of dealing with the high speed IoT sensor data to optimize processes in real-time to maximize quality and minimize production cycle-time .
Therefore , in order to dynamically improve the overall manufacturing efficiency in terms of drug quality and plant performance , the process validation system should be enhanced with APC capabilities that leverage big-data and advanced analytics driven IoT solutions . This is needed to scrutinize massive amounts of sensor data being collected by their smart machines and provide real-time predictive and prescriptive process improvement opportunities . Thus , IoT-Enabled process validation system with APC capabilities have the potential to play a significant role in optimizing processes in real-time to achieve high drug quality .
PATENTS AND GLOBAL PV SYSTEM FOR COVID-19 VACCINES
Once a biopharma company succeeds in developing and testing COVID-19 vaccine , they would soon be applying for FDA drug approval for commercial production . However , the traditional approach to commercial rollout i . e ., strict patents ; is not going to work in case of COVID-19 vaccine . This pandemic is too big and important for any single company to be allowed to hold onto the manufacturing process rights . It is also practically impossible for a single company to produce vaccines that can cater to global demand .
Instead , it seems likely that once a vaccine is approved , its manufacturing will be licensed and outsourced extensively to other biopharma manufactures or biopharma contract manufacturing organizations ( CMOs ) around the world for mass production . For Example , AstraZeneca has the exclusive rights to one of the frontrunner vaccines , which initially was developed by Oxford University in the UK . AstraZeneca has , in turn , signed sublicense agreements with several producers to increase the supply of the future vaccine . These include the Serum Institute of India , one of the world ’ s largest vaccine producers , and Fiocruz in Brazil , as well as several producers in
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