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Process Validation Stages process design two


In Process validation the first stage that is Process design stage have some points which are taken into account. Some of them which are taken into consideration are as follows:

Process control should address variability such as:

During the process design the control to reduce the input variation and the control to adjust for input variation are taken into account during manufacturing.

Controls may also consist of about the equipment monitoring at significant processing point and also control on material analysis.

Use the risk assessment for the extent and the type of process controls.

Also take into consideration the operational limits and the in process monitoring during process design. 



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