What Are IQ, OQ, and PQ, and Why Are They Required In The Pharmaceutical Industry?

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SOURCE:http://www.wellspringcmo.com/blog/what-are-iq-oq-and-pq-and-why-are-they-required-in-pharmaceutical-industry

by Wellspring Pharma Services

Pardon the alphabet soup, but these acronyms identify common terms that you’ll see in many FDA and Health Canada 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 utilize to the exact materials used in its construction.

Once you have your final/approved design specs, 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 Accomodating 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.

Qualification Processes Will Give You, And Your Client, Peace Of Mind

WSS011Why does the pharmaceutical manufacturing industry need this qualification process? Validation executed as a global exercise, is a method of establishing documented evidence that shows that we have a high degree of assurance that our manufacturing process will consistently yield a product of predetermined quality. If a manufacturer fails to do that, the results can be disastrous. It can cost the client hundreds of thousands of dollars, increase the risk of product recall and potentially contribute to a loss of market share. We try to prevent that, and we do so by controlling change and ensuring that we account for change in our day to day operations.

Occasionally, we get clients who ask, “can you make this product for us?”  We may not have the specific equipment needed, but the client wants our involvement and would like us to bring the equipment in. The IQ, OQ, PQ process is very important here. We’ve helped clients spec out the equipment they need and then quickly and efficiently bring that equipment in, install it, set it up, and get it ready to go.  The way we run the IQ, OQ, PQ process really expedites the transfer of a product into our facility.

In one case, we obtained approval from a client in February, spec’d out the equipment, received it in March, set it up and began manufacturing clinical trial batches and brought them to the clinical site by September 1st. Due to the rigorous process we go through, we identified the equipment, knew what we had to do to get it up and running optimally and did it quickly. That really helped our client.

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