The Food and Drug Administration (FDA) defines qualification as “activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly.” The definition adds that these activities are to precede the manufacturing of products on a commercial scale. Qualification is broken down into three distinct phases: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). In this article, we will look at each of these phases and determine their role in the quality assurance requirements of industries that are heavily regulated.

Why IQ, OQ, and PQ?

The qualification steps involved in the validation process are covered in parts contained within 21 CFR (Code of Federal Regulations) 211 (pharmaceuticals) and 21 CFR 820 (medical devices).  They are enforced by the FDA where validation is a reference to the use of objective evidence.  This evidence is used to confirm that a process, along with equipment used as part of that process, consistently meets the intended specifications.  This process is used when verification through the use of direct examination is not possible or feasible.  It may sound complicated, but it is not intended to be that way. Each step has to be completed before moving onto the next one.  The IQ OQ PQ process provides a simple way to qualify equipment that is expected to be used repeatedly in industries where quality standards must always be at the highest acceptable level. According to this Dickson guide, IQ OQ PQ is the widely accepted standard for maintaining product quality in regulated industries.

What Is Installation Qualification (IQ)?

IQ has two primary goals.  The first is to verify that the specifications of the delivered equipment match those set by the process design. In other words, making sure you have the right equipment for the task.  The second goal is to verify the equipment has been properly handled, delivered, and installed for use. Before the IQ phase can be passed, installation must match the requirements of the equipment manufacturer. This includes:

  • location/floor space
  • access to a recommended energy source
  • correct operating and environmental conditions
  • that the equipment has been unpacked and checked for damage
  • that the contents have been cross-checked with the packing list
  • confirming all connections and communication paths are attached correctly
  • recording validation and calibration data used for IQ

Essentially, the goal of IQ is to determine that the system under validation can run. The next step is to determine how that system runs. When all of these factors have been completed, the process moves to the second phase, Operational Qualification (OQ).

What is Operational Qualification (OQ)?

In this phase of the process, the operational parameters of the equipment are examined to understand how they will affect the in-process material. OQ has two principal parts. The first confirms that the equipment does indeed operate according to the manufacturer’s specifications as verified during IQ.  The second part is to determine how the operational parameters of the equipment will affect the properties of the material being processed.  If any modifications are made to the equipment when going through the validation process, it will have to be re-qualified to ensure that the alterations do not hamper the way the equipment is to perform according to the manufacturer’s specifications. The OQ checklist involves the following:

  • LEDs and display units
  • controls for temperature
  • controlling systems for vacuum/pressure
  • fans and speed controls
  • systems for measuring and controlling humidity
  • air-flap controls and servo motors
  • controllers for card access and reading
  • temperature distribution compliance

After all the working parts have been confirmed to do what they are intended to do, the final phase of the process, Performance Qualification (PQ) can begin. The goal of PQ is to test those limits that were determined in OQ.

What Is Performance Qualification (PQ)?

The final phase of the IQ OQ PQ process confirms that the equipment functions as it is designed to do through actual processing conditions. Before PQ can begin, an in-depth assessment plan must be created. There are specific guidelines set out by the FDA relating to the PQ process; they form the PQ protocols. They include:

  • conditions related to the manufacturing aspects of the limits of the equipment, the operating parameters, and component inputs
  • a collection of data recorded and analyzed during tests, calibration, and validation exercises
  • specific tests to be conducted to ascertain quality consistency at various stages of the production process
  • a sampling plan that explains the methods used for samples during and between production runs
  • a methodology for analysis for data, scientific, and risk-oriented decisions using statistical data

The Point Behind IQ OQ PQ

In simple terms, the whole idea that puts IQ OQ and PQ into perspective is that it is a well-planned and performed three-step validation system.  The results of such an organized process are critical to confirming that the equipment under scrutiny is well-controlled and can consistently meet quality standards through the manufacturing cycle.  For settings where mass production is the basis of the process, having a failure of any kind can be costly in many different ways. So, to prevent this from happening, the protocols set out in the IQ OQ PQ three-step system prove that the equipment works properly at the time of testing and will continue to do so.

Conclusion

Regulated industries rely on equipment that operates correctly when it is needed to operate. Plus, when equipment operates correctly, it can meet quality standards consistently. To ensure this happens, the FDA has developed a simple, three-step cycle that, when followed, provides validation that the equipment performs as it is intended to do.  As simple as that sounds, specific steps must be followed to pass from IQ to OQ and onto PQ.  Considering that these three steps are in place to ensure the safety of those using the equipment as part of the process, it only makes sense to do whatever is necessary to meet the guidelines set forth by the FDA.