Performance Qualification

What is the validity of performance qualification of any equipment?

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The validity of performance qualification is based upon criticality of that equipment and use. While doing initial qualification of equipment , you need to establish the validity and it should be tracked through VMP. For some equipment, where the performance is monitored daily, a risk assessment shall be done and based on this assessment periodic requalification is not required.

Performance qualification means that you verify that the equipment is able to perform as desired in your setting. Meaning that you establish that it is capable, for instance, to produce your product within your specifications.
What tests you need to perform in order to do this are defined in a process risk assessment, where you define the critical quality attributes, validation approach etc.


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