You are here

Process Validation Stages process qualification one


In Process Validation the second stage that is process qualification , the design of the facilities and the qualification of the equipment and the qualification of the utilities are very important. Some of the points regarding design and qualification are as follows:

During the qualification of th utilities and the equipment, the construction materials, the operating principle and the performance characteristics are very important.

The verification of the utilities and the equipment are carried out whether they are installed as per the design qualification or not.

Verification of the equipment is carried out whether it is working at all operating range or not.

Risk assessment is to be performed during performance and documentation.

Proper plan is made for studies or test to use, time for various qualification activities, plan for responsibility of relevant department and the quality department and the procedures for documenting and approving the qualification activities.