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Process Validation Stages process qualification two


In the Process Validation during second stage that is process qualification some more points are taken into account which are  discussed below. So let us see some points one by one:

During process performance qualification the actual facilities, utilities and equipment are checked whether they are qualified or not.

The personnel operating various equipment are trained or not is checked.

The  procedure which are performed are as per standard procedure is verified and checked.

The components which are going to use for the commercial manufactured are also checked and verified.

Performance qualification confirms process design.

Overall level of product and the understanding of process is necessary during performance qualification.

Data from lab, pilot and commercial batches are studied.

Previous experience of similar batches and products are also taken into account.

Higher level of sampling is required during this stage.

Additional testing is done if required.

Adequate measure are taken out to achieve adequate quality of product.



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