Hi I will like to know does offsetting of equipment require a redo of 3 runs of performance qualification of the equipment?

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Continuing the discussion from Requalification / Revalidation of Equipments and Instruments:

Continuing the discussion from Requalification / Revalidation of Equipments and Instruments:

Continuing the discussion from Validation plan vs. Validation protocol:

2

In short yes! After the investigation under CAPA, unplanned deviation, and an assigned cause. Maybe your equipment is just not capable. Prove me wrong!?

3

Hi I was wondering could i just do calibration and then perform a worst case run ? If afterwhich the ressults still fall within specs then i don need to do 3 run PQ again ?

4

Depends on the conclusion of your investigation. Equipment may be calibrated but not capable of making the drug product! An example would be a centrifuge that passes calibration at 60,000 rpm but the manufacturing process requires a centrifuge that can run at 100,000 rpm. Therefore, the centrifuge is not capable!