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Process Validation Stages process qualification


During Process validation: The second stage is process qualification Some of the points which are discussed during process qualification are as follows , so let us check it out points one by one.:

The main aim of process qualification is to determine whether the process which is designed is capable of reproducible commercial manufacture or not.

Design of the utility and the qualification of the equipment are taken into account during process qualification.

Process performance qualification in this stage.

Completion of this process qualification stage is required prior to commercial distribution.

The products which are manufactured during this stage can be sent to distribution if they are acceptable.

Qualification assures that the utilities and the equipment are suitable for their intended use perform properly.