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Process Validation Stages


Process Validation is divided into three stages, So let us check it out one by one. Following are the three stages.

Stage I - Process Design: With the knowledge of Scale up studies and the prior knowledge which is gained through development, The commercial manufacturing process is defined during this stage of process design.

Stage II - Process Qualification: After defining process design, it is evaluated in this stage to determine whether the process is capable of reproducible commercial manufacturing or not.

Stage III - Continued process Verification: Continuous assurance of the ongoing process during the routine production to check the process remains in a state of control.


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