Validation

 

You will find IQ OQ PQ in many FDA and MHRA guidance documents, and typically refer to equipment.

 

IQ stands for Installation Qualification. OQ is Operational Qualification and PQ is Performance Qualification.

 

Before you even get to IQ, OQ, PQ, if you’re acquiring a new piece of equipment, you’ll need design specifications that define exactly what’s in that  piece of equipment. Everything from the type of power source it will utilise to the exact materials used in its construction.

 

Once you have your final/approved design specifications, you order the equipment, it comes in and now you’re developing your IQ and OQ. Quite often, the basis for the IQ and OQ will be the equipment manual itself. To save time and, prior to delivery, we’ll ask the equipment manufacturer for the manual and we’ll use the manual as the basis of our protocols.

 

Installation Qualification (IQ) Evaluates Means Of Accommodating New Equipment And Testing Its Materials

 

For installation qualification, we’ll first look at the equipment material. For example, if we specified 316 stainless, we’ll test to verify it is in fact 316 stainless. Sometimes stainless steel is passivated and you can test to verify there are no further residues from the passivation process.

 

You might have specified a 5 force power motor in your equipment, for example. You want to check to ensure it’s a 5 force power motor. You’ll also confirm that the power output and the power requirements are consistent with your specifications, and the room that the equipment is installed in can accommodate that power source. Once you have completed your review of the installation and everything is in order, you can trust that the equipment is going to operate the way in which it was designed.

 

Operational Qualification (OQ) Is Essential In Challenging Your Equipment Parameters

 

The next phase is OQ, operational qualification. At this stage, if you’ve specified that your equipment is going to run in a range of 50-150 RPM and will draw a specific amount of power, you want to verify that the equipment is achieving those operational requirements. So, review those parameters and challenge them. Again, make sure your equipment actually runs the way it’s supposed to run.

 

Performance Qualification (PQ) Puts Your Equipment To The Final Test

 

In the PQ - performance qualification – phase, we like to challenge the equipment, much like in the OQ phase, but now under load. While it’s great that it runs at 50 RPM or 150 RPM when it’s empty, what happens when there’s 300 kilos of material in it? Can it still achieve those speed ranges? That’s the essence and focus of the PQ phase. Once you’ve completed these three phases, the equipment is available for use in whatever process you intended for it.

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