IoT-Enabled Global Process Validation System
high-income countries . 4 This , however , makes it difficult for the parent company or a regulatory authority such as FDA to monitor and govern the manufacturing processes followed across licensed companies which is essential to ensure the production quality of the vaccine .
Hence , in order to accelerate the global production rollout while maintaining high degree of compliance with the originally validated process , an overarching consolidated process validation system with APC capabilities is essential . It consolidates data from all the licensed companies ’ production systems such as Manufacturing Execution Systems ( MES ), Laboratory Information Systems ( LIMS ), Electronic Batch Record System ( EBRS ) etc ., and provides predictive and prescriptive process improvement insights . This consolidated system not only helps in a quicker replication of the original process validation system by the licensed biopharma companies and CMOs directly reducing initial set-up time , but also helps the patent-holding biopharma company and the regulatory bodies such as FDA or WHO to govern and ensure that high degree of international quality and safety standards are met with minimum delays and errors .
Fig . 2 : COVID-19 global process validation System concept diagram
- 42 - November 2020