In regulated industries, like pharmaceutical manufacturing, food production, aerospace, and others, IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) are part of the processes of adding a new piece of equipment or software to the production/research line. These steps ensure that the new equipment is 1) the correct equipment, 2) works as intended, 3) is installed correctly, and 4) performs as intended after installation.
These steps are vital to ensure consumer and public safety. The wrong piece of equipment or one that’s improperly installed can compromise the entire production or research line.
By using these validating steps, manufacturers and researchers have control over even the tiniest inconsistencies in their process, preventing possible malfunctioning of their final product.
In this blog, we’ll look at each of these steps and their effect on product quality, along with some examples.
For more on each step in the IQ OQ PQ Process, Dickson has a detailed guide.
Why are IQ OQ PQ required?
These processes are required under federal law (21 CFR) which covers food and drugs and are enforced by the Food and Drug Administration (FDA). The goal of the laws is to maintain Good Manufacturing Processes (GMP). Because the industries and the FDA recognize that good manufacturing practices are a constantly evolving process, the term “current Good Manufacturing Practices” (cGMP) is used to clarify that the FDA is looking for manufacturers to meet the spirit of the law, not just the letter. The FDA provides more details on cGMP on a webpage that’s updated as the laws change.
The FDA requires IQ, OQ, and PQ as part of the manufacturing process. Each step must be documented and detailed to prove and ensure that cGMP has been the guiding principle in the purchase, installation, and activation of new equipment or software in any regulated industry.
What does qualification mean in IQ, OQ, and PQ?
The first definition to understand is how “qualification” is used in this context. Qualification in the context of these FDA laws refers to “activities undertaken to demonstrate” that a device or other new piece of any manufacturing or research process actually does what it’s intended for. Each of these steps is required, and must be documented, before any device or software can be used for commercial production.
A Preliminary Step to IQ
Prior to installation qualification (IQ), the manufacturer and its supplier must follow a preliminary step: DQ (design qualification). In this step, both the purchaser (the manufacturer) and the supplier (the company providing the new equipment or software) confirm that the device being purchased will work for its intended purposes. Specifications, such as temperature, design, function, power requirements, and more, must align with the location and requirements of the equipment intended for use in production.
The DQ step is important. It’s part of the process to ensure that a manufacturer is ordering the piece they need and one that will fit into the production line as intended.
What is IQ?
IQ refers to installation qualification. IQ is the step in the process that shows that the right piece of equipment was delivered to the manufacturer or laboratory and that it was installed according to design/manufacturer’s specifications.
For example, if a brewery is expecting a new brew tank, the brewery verifies that the delivered item is a) the correct item and b) is properly installed according to specifications. As with each step, IQ must be documented with objective confirmation and properly recorded.
What is OQ?
OQ stands for operation qualification. This is the step in the process where the responsible parties verify that the machine or software operates within specified limits. The manufacturer simulates the load the device will experience under normal circumstances to guarantee that the new equipment can handle the load.
In the brewer’s case mentioned above, the brewery uses the brew tank in isolation to guarantee that it can withstand the pressure created by brewing, that it achieves the correct temperatures, and that all valves and piping withstand the opening and closing needed to make and process beer.
What is PQ?
PQ refers to process qualification. At this stage, the device or software is used in its normal capacity in a simulated environment. The final product won’t be sold or released to the public, but the new piece of the production process would be used in its full context.
The brew tank is now used to make beer. The mash is moved to the tank, the beer ferments, and it is sent to bottling or service taps. At each step of this process, the product is tested for quality to ensure it meets safety guidelines and operates as expected.
A Follow-up Step
A follow-up step to PQ is often included: MQ (maintenance qualification). At this stage, maintenance requirements are defined, a procedure is put in place to make certain that those procedures are followed, and maintenance is fully documented.
The Natural Process
IQ, OQ, and PQ are, in fact, a natural part of the processes of installing new equipment. The difference is that the FDA requires documentation that every step was taken in a meticulous and professional fashion.
Imagine you’re going to buy a new toaster for your home. You decide how large it will be and how many slices it will handle (DQ). You purchase a toaster that meets your needs at the store, bring it home, and plug it in (IQ). You use it to make toast the first time knowing that the toast might not be quite right because of coatings on the interior of the toaster (OQ). Next, you use the toaster to make breakfast for the family where you might need to use it several times in a single morning (PQ). You’ll occasionally shake out the crumbs and wipe down the exterior of the toaster (MQ).
For regulated industries like pharmaceutical and medical device manufacturing, food and beverage manufacturing, as well as research and development laboratories, laws exist to ensure that these steps are followed and documented. Cutting corners on these steps with a toaster might lead to burnt toast, but for a food manufacturer, it could lead to making consumers ill or even killing someone.
By following each step meticulously, a manufacturer ensures that product quality remains high because the equipment or software being added meets the criteria.