IoT-Enabled Global Process Validation System
As per the US Food and Drug Administration ’ s guidance , there are three stages of process validation :
1 . Stage 1 – Process Design : A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control , based on sound science and quality risk management
2 . Stage 2 – Process Qualification : The process design is evaluated to determine if it is capable of reproducible commercial manufacture . This stage has two elements : ( 1 ) design of the facility and qualification of the equipment and utilities and ( 2 ) process performance qualification ( PPQ ). This should be completed before release of commercial lots .
3 . Stage 3 – Continued Process Verification ( CPV ): Collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits assuring that processes are in a constant state of control , thus certifying final product quality .
Fig . 1 : Three Stages of process validation 3
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