12/4/2020 Guide to IQ OQ PQ for the Pharmaceutical Industry

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IQ OQ PQ for Pharmaceutical

What Is IQ OQ PQ?
In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous
and potentially deadly consequences. This is why reliable equipment validation is so critical in the
pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for
pharmaceutical industry purposes.

What Do IQ, OQ and PQ Mean?

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification,
respectively. They represent quality assurance protocols for each phase of the manufacturing process for
pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential
to follow IQ, OQ and PQ protocols.

Installation Qualification (IQ)

Installation qualification, or IQ, is a documented verification process that the instrument or piece of
equipment has been properly delivered, installed and configured according to standards set by the
manufacturer or by an approved installation checklist.

Installation qualification requirements for equipment include checking for proper location, proper energy
supply and acceptable environmental conditions. There is also checking of contents against the packing list,
verifying software installation, documenting computer-controlled instrumentation, verifying connections with
peripherals, and recording calibration and validation dates, among others.

Operational Qualification (OQ)

Operational qualification is the next step in quality assurance and involves testing the equipment and making
sure it performs as specified, within operating ranges as listed by the manufacturer. All aspects of the
equipment receive individual testing and the tester documents the proper operation of each.

Operational Qualification for equipment is necessary after installation, significant maintenance or

modifications to the equipment, or as a feature of scheduled quality assurance testing. Operational
qualification aspects that will be tested may include leveling and fluctuation, repeatability, keyboard controls,
deviation reports, calibration and certificates, as well as performance reports.

Performance Qualification (PQ)

Before your equipment can be truly rated as qualified, you will need to put it through performance
qualification. Your process performance qualification protocol will feature verification and documentation that
all equipment is working within the accepted range as specified, does it perform as expected under real
conditions. All instruments are tested together according to a detailed test plan and must generate
reproducible results.
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12/4/2020 Guide to IQ OQ PQ for the Pharmaceutical Industry

Performance qualification protocols and validation should typically include but not be limited to:
Precision Solutions is identified as a life-sustaining business, and we are continuing to serve our customers’ needs. Contact Us

Data summary — A list of data that needs to be analyzed or recorded during the testing procedure
Manufacturing conditions — Such as component inputs, operating parameters and equipment environment
Calibration and validation
Sampling plan — What sampling methods are used (if applicable)
Analysis methodology
Variability limits
Nonconformance contingencies
More on Quality Assurance for Your Pharmaceutical Equipment with Precision Solutions, Inc.

Consumer confidence is more vital in the pharmaceutical industry than in almost any other industry. When
asking people to put their lives and their health in your hands, you need to give them every reason to have
complete faith in your products. Precision Solutions, Inc. has Certified Weighing Technicians trained to work
with your IQ OQ and PQ validation within USP 41 Standards. Partnering with industry leaders such as
Sartorious, Minebea and Ohaus you can ensure we’ll have the right equipment for your lab and it will be
properly validated.

CONTACT US FOR A QUOTE OR SCHEDULE AN APPOINTMENT >> 

By enforcing extensive and comprehensive IQ, OQ and PQ protocols in your business, it’s more likely you
have equipment that is consistently accurate, reliable and high quality. This means you are better able to
produce products your customers can rely on.

For reliable, accurate measuring and testing equipment for your pharmaceutical needs, contact Precision
Solutions Inc. today.

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Precision Solutions is identified as a life-sustaining business, and we are continuing to serve our customers’ needs. Contact Us

2525 Tollgate Road, Quakertown, PA 18951

Phone: (215) 515-2775

Fax: 215.536.4096
Email: info@precisionsolutionsinc.com
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