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IoT-Enabled Global Process Validation System
INTRODUCTION
Connected As the COVID-19 pandemic is hitting the second wave across many nations , soaring up the total no . of COVID-19 positive cases around the globe , the world is yet again facing major healthcare and life sciences challenges , such as non-availability of hospital beds , scarcity of medical and paramedical staff and shortage of medication , medical devices and disposable medical equipment , etc .
On one hand , the world eagerly awaits vaccines to be successfully developed & tested by biopharma companies that can prevent public from getting infected by the deadly virus while ensuring utmost patient safety and on the other hand the FDA and pharmaceutical companies are working extensively to address the sudden
shortage 1 of various drugs in the market including drugs related to COVID-19 caused due to interruptions in the manufacturing and supply chain caused by the pandemic and surge in demand for COVID-19 related treatment drugs .
This paper discusses how Industrial IoT ( IIoT ) -enabled Global Process Validation system with Advanced Process Control ( APC ) capabilities can be a game changer in accelerating the manufacturing efficiency , production capacity and reducing production cycle time for both chemical drugs and biologics to ensure availability of drugs while maintaining high process validation compliance that assures maximum quality ensuring patient safety .
PROCESS VALIDATION AND THE ROLE OF IOT ANALYTICAL CAPABILITIES
As per the World Health Organization ( WHO ), Process Validation ( PV ) 2 is the collection and evaluation of data , from the manufacturing process design stage through commercial production , which establishes scientific evidence that a manufacturing process is capable of consistently delivering quality products that meet the products ’ predetermined specifications and quality attributes . Process Validation not only offers assurance that a process is reasonably protected against sources of variability that could affect production quality , but also proves that in spite of any unavoidable variations in operational parameters through the necessary scale up of the production process , including new facilities and equipment , the final product quality characteristics are not compromised .
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