Most people don’t know what IQ OQ PQ stands for, but in heavily regulated industries, it can’t be ignored. All essential equipment must pass through the IQ OQ PQ validation gauntlet before it can be placed into service. Otherwise, the organization that operates the equipment could face stiff fines or even enforced closure. 

IQ OQ PQ is an abbreviation for the process of validating the proper installation and functionality of a piece of equipment. It is a component of quality assurance, the process by which regulated industries validate their compliance with applicable industries. 

The components of IQ OQ PQ are as follows:

 

• IQ — Installation Qualification. Validation that the equipment has been installed properly, according to manufacturer specifications. This might include making sure the equipment has adequate space and clearance, the electrical requirements are met, the machine is level, all materials in the manual were included in the packaging, and that all components are made from the materials they claim to be made of. IQ must be validated after the first installation and may need to be revalidated annually or after upgrades and major service.

 

 

• OQ — Operational Qualification. Validation that the components of the equipment perform as expected, according to manufacturer specifications, in non-operational conditions. OQ must be validated after the first installation and may need to be revalidated annually or after upgrades and major service. 

 

 

• PQ — Performance Qualification. Validation that the equipment performs as expected in operational conditions, performed before the equipment gets put into service. PQ must be validated after the first installation and may need to be revalidated annually or after upgrades and major service. 

 

Here are five things to know about IQ OQ PQ:

1. It applies to a variety of regulated industries.

IQ OQ PQ applies to a number of industries that face significant regulatory burdens since these sophisticated industries often rely on sophisticated equipment. Examples include:

 

• The Aerospace Industry. Equipment necessary for the aerospace industry includes bevelers, crimpers, benders, air compressors, grinders, roll formers, punches, and presses.

 

 

• The Medical Device Industry. Equipment necessary for the medical device industry includes simulators and testing equipment, packaging equipment, and 3D printers.

 

 

• The Food Industry. Equipment necessary for the food industry includes scales, pressure gauges, refrigerators, freezers, grinders, ovens, mixers, conveyors, pump feeders, size reducers, and delumpers.

 

 

• The Pharmaceutical Industry. Equipment necessary for the pharmaceutical industry includes agitators, boilers, blowers, chillers, centrifuges, granulators, heat exchangers, metal detectors, sifters, presses, ovens, and pulverizers.

 

2. It is required to maintain compliance in many cases.

IQ OQ PQ isn’t just to verify to the organization for its own sake that they have not received faulty or improperly installed equipment. Quality assurance is a mandatory component of regulatory compliance. 

Watchdog agencies pay careful attention to the equipment validation documentation included in the IQ OQ PQ process. Organizations in these industries may face backbreaking fines and forced closure if they don’t perform proper IQ OQ PQ.

Regulations that require IQ OQ PQ include FDA 21 CFR 820 and ISO 13485.

3. It helps to have outside expertise.

Regulations are not known for their pith and concision. In fact, they can be bulky and arcane. Lay users may find the regulations that apply to their organizations hard to understand. 

But the user-friendliness of the regulations is immaterial. Heavily regulated businesses must comply with applicable regulations or face fines and closure. However difficult it might be, organizations have to get compliance handled. IQ OQ PQ is no exception. 

Larger organizations may establish an in-house compliance division, staffed by experts whose sole job is to make sure the company complies with relevant regulations. IQ OQ PQ would fall under the purview of such a compliance division.

However, other organizations may not be able to afford a separate compliance division, or otherwise lack the resources or the desire to create such a division. In this case, compliance validation can be outsourced. Third-party compliance experts can offer an affordable, efficient alternative to establishing an in-house compliance division. 

4. It can be costly if conducted improperly.

We have mentioned it before, but it bears repeating — the consequences of failing to properly validate IQ OQ PQ can be dire. Penalties include hefty fines, seizures, injunction, civil penalties, even prosecution. 

Validation must be complete, timely, and conform to the requirements of the applicable regulation. For example, according to FDA 21 CFR 820.70(g), IQ must consist of:

 

• Maintenance Schedule. Schedules for cleaning, adjustment, and maintenance according to manufacturer specifications, including the date and responsible persons or departments.  

 

 

• Inspection Validation. Inspections to conform with manufacturer specifications with established procedures, inspection dates, and inspectors named. 

 

 

• Adjustment Validation. Periodic adjustment, with limitations and allowances clearly posted and responsible personnel named.

 

 

• Automated Processes Validation. Validation of all computers, automated processes, and data processing equipment. 

 

5. It’s particularly important in pharmaceuticals.

Several industries must pay scrupulous attention to IQ OQ PQ validation, but the pharmaceutical industry bears a special burden. Pharmaceutical development and manufacture is a particularly equipment-intensive industry. 

Moreover, the output is a consumable product, which raises public health and safety concerns. Ultimately, the quality of the product could mean the difference between life and death for patients depending on the medication for survival. 

The COVID-19 pandemic has refocused the attention of the world on the lifesaving mandate of the pharmaceutical industry. With all eyes on them, pharma can’t fall asleep at the switch. Too many people depend on them. Smaller pharmaceutical companies must perform IQ OQ PQ validation to help maintain public trust in the industry. If they don’t maintain an in-house compliance team, it’s worth it to outsource IQ OQ PQ validation to professionals and get it right.

Dickson goes into greater detail on the role IQ OQ PQ plays in pharma in their guide.

Heavily regulated industries tend to rely on sophisticated equipment. Moreover, better and better equipment is constantly under development, meaning the validation of that equipment is an ongoing process. With proper attention to IQ OQ PQ, organizations can remain compliant and enjoy many years of profitable, productive service from their magical machines.