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Process Validation Types Revalidation

Posted on July 14, 2014 By Frndzzz

Fourth type of process validation is Revalidation. It is performed to check the performance of the various process parameters, some of the points regarding revalidation are as follows. So let us have a look on revalidation:

Any part of process or entire process parameters are validated in order to check the performance of the process parameters.

To maintain the validated status of equipment, facilities, or manufacturing process , revalidation if often carried out.

Revalidation is generally performed when product from one plant it transferred to another plant.

If there is any change in the process parameters or the product quality then revalidation is performed.

There is periodic checking of all the process parameters.

If the batches fails to meet the specifications and this (OOS) repeated in sequence then revalidation is done.

The revalidation of manufacturing process depends on the changes of any process parameters, facilities or any change in the equipment parameters .

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