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BLOG

What Are IQ, OQ, and PQ, and Why

Are They Required In The
Pharmaceutical Industry?
Posted by Wellspring Pharma Services
May 15, 2014 10:25:00 AM
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
Why 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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Topics: Quality & Regulatory
ABOUT THE AUTHOR
Wellspring Pharma Services
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WellSpring Pharma Services is a full-service provider of pharmaceutical contract
manufacturing and packaging outsourcing solutions for solids, semi-solids, and
non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing,
packaging and analytical testing services from a single FDA inspected and
Health Canada licensed facility.

Comments
archana nehru
5/22/2014, 1:54:41 AM
Good article, very simplified explanation in IQ, OQ, and PQ. We have a similar
process in electronics. Our industry is not as regulated as pharmaceuticals, and
this identifies some of the qualification tests we can create around the specs to
meet the criterions of IQ,PQ, and OQ.
Reply to archana nehru

Denizhan Savaş
2/28/2018, 4:57:40 PM
Hi, do you have a document for the PQ test? As an example.
Reply to Denizhan Savaş

Sam Ricchezza
2/28/2018, 9:23:57 PM
Thank you for your question. "PQ" or Performance Qualification is performed
product by product. This is the part of the product validation process and is
typically governed by a Validation PRotocol that is designed and written
specifically for that product. Each product will have unique validation parameters
that need to be met.
As such, there is no general form that is generally used, since the parameters
can change product by product.
Reply to Sam Ricchezza
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