Performance qualification of Equipment in Pharma

-In Performance qualification ensure that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods.

-It provides the documents evidence that the equipment perform.

- Performance qualification is performed after successful completion installation qualification and operational qualification.

-The PQ represents the final qualification of your equipment or system.

- Performance qualification include following checkpoints: 

         - Perform the operation into the equipment by using raw materials, or  substitutes 

- Processing steps including variables and tests to include conditions covering upper and lower operating limits.

-Critical process parameters 

-Challenge steps (where applicable)

         - Operating parameters and equipment limits

         - It shall cover the operating range of the critical process parameters.

         - Tests to performed to ensure quality at each production

-After completion of the performance qualification of the equipment can be used for routine manufacturing activity; however process validation shall be performed before starting the routine manufacturing activity .Process validation may be combine with the Performance qualification.