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IQOQ, and PQ are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products.

In each phase of the validation process, documents are compiled with detailed results of each qualification test. After performing IQ, OQ, and PQ successfully with the desired result and established documents that verify each phase, a manufacturing process can get underway. The defined discipline for a validation process has proven to be the ideal way to guarantee the best quality of medical devices consistently over time.

Any medical device manufacturing processes where the result is not verifiable by subsequent monitoring or measurement must be validated. A validation plan should be established including the steps of IQ, OQ, and PQ for each process. The approach should be risk-based to ensure critical parameters or specifications are adequately taken care of.

IQ is the first step in the validation process. In this phase, you verify that the manufacturing equipment meets the design specifications and has been correctly installed and configured according to requirements. You need to confirm that all necessary documents, drawings, and manuals are correctly executed and available. During IQ, equipment maintenance as well as calibration schedules and procedures should be established.

PQ is the third and last step of the validation process. In this phase, you verify process stability over time by running the equipment several times with a load under normal operating conditions to challenge its functionality and safety. This will demonstrate if the process will produce a product that conforms to its requirements.

Medical devices are intended to be used for humans and need to meet regulatory requirements. IQ, OQ, and PQ are important steps in a validation process to prove that the medical devices meet all predetermined requirements for functionality and safety, as well as the regulatory standards. Non-conforming products could lead to human injury and result in costly product recalls. A well-planned and performed validation process is crucial for manufacturers to ensure that they have a controlled manufacturing process that consistently produces conforming products that ensure the quality and safety of the medical device.

IQ, OQ, and PQ should be carried out by the manufacturer according to the FDA and ISO standards. Read more about these standards and the tasks associated with IQ, OQ, and PQ validation in the links below. Also, the GHTF (Global Harmonization Task Force) provides guidance that clarifies how to act. (The guide is an internationally harmonized document recognized by both the FDA and ISO).

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As a quality assurance component, equipment validation is critical to producing consistent, high-quality products. One of the key sets of protocols within equipment validation is Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

IQ, OQ, PQ protocols are methods for demonstrating that equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements.

For example, a physical instrument or tool may require a specific amount of floor space, certain operating conditions, and an assurance that no damage exists on the unit. For software, IQ typically involves (but is in no way limited to) verifying folder structures are correctly established and ensuring that the minimum system requirements are met.

After the initial IQ, re-qualification must be performed following any major maintenance or when equipment is modified. Re-qualification should also be performed as part of routine quality assurance processes.

Ensure that all individuals involved in executing the IQ protocol are trained on the equipment and the importance of thorough and accurate documentation practices. This training should emphasize the role of documentation in regulatory compliance and quality assurance.

During OQ, all items in the test plan are tested and their performance is thoroughly documented. Since this is a prerequisite for acceptance of equipment and the facility, it can only be conducted once the IQ is run.

The final step of qualifying equipment is PQ. In this phase, the qualification and validation team verifies and documents that the user requirements are verified as being met. These user requirements should include the normal operating range required (as defined and signed off on by QA and verified in the DQ). Once you've qualified the equipment, you can develop each process required for each product. Then, once each process is fully developed, it can be validated.

The Process Performance Qualification (PPQ) protocol is a fundamental component of process validation and qualification. Its purpose is to ensure ongoing product quality by documenting performance over a period of time for certain processes.

Diagramming that out, on your own, you have several ways of doing that. You have your value chain analysis. You have your Kano diagram, you have customer surveys. [All of these tools help you] interpret [requirements] at an engineering level. If you've met what the customer wants, then that's what success is. If you've met the expected lifetime that you have chosen for that device to have, then that is what success is.

Rather than filling a traditional full-time role, many life science organizations work with resourcing firms that can locate and place qualified professionals through a flexible contract staffing/staff augmentation model.

Unlike traditional full-time hiring, a flexible contract staffing model combined with a large, global staff of qualified personnel enables better adjustment with cyclical or project-based demand while infusing new skills and experiences into the team.

Want to learn more about building an effective qualification and validation team? Grab our free white paper below. Need a life science specialist or team to support a current or upcoming project? Submit the form below to tell us a little about yourself and your project or resource needs. We'll follow up within one business day.

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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.

The meaning of IQ, OQ and PQ are 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, 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 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.

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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