IQ, OQ, PQ_ A Quick Guide to Process Validation

In the medical device industry, even one failure in a process can lead to devastating consequences for patients. Devices need to work exactly as they’re supposed to, every time they’re used.

One of the ways medical device companies can ensure that outcome is through process validation. Process validation is a means of ensuring that a manufacturer has the processes in place to produce devices that perform their function consistently over the long-term. 

Process validation consists of three steps—IQ, OQ, and PQ—and is fundamental to getting safe, effective medical devices to the market.

BONUS RESOURCE: Click here to download this free Master Validation Plan (MVP) form to document a list of all of your company's processes that require validation.

IQ, OQ, PQ - what are the three phases of process validation?

In its guidance on process validation, FDA states that process validation is “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

In 21 CFR 820, FDA also states that process validation should occur “where the results of a process cannot be fully verified by subsequent inspection and test.”

In practice, this often includes processes like:

  • Sterile package sealing

  • Aseptic filling

  • Welding, soldering, painting, or heat treating

  • Injection molding

In the case of sterile packaging, for example, verifying the result would require opening it—thereby destroying the packaging and rendering the sterilization process moot. 

In such cases, manufacturers can use process validation to ensure that their process produces an outcome or product that is safe and consistent over the long-term. The three stages of process validation are known as IQ, OQ, and PQ, which translate to:

  • Installation Qualification (IQ) - Installation qualification is used to ensure that the installation of any necessary equipment, piping, services, or instrumentation has been executed in accordance with the manufacturer's requirements.

  • Operational Qualification (OQ) - During operational qualification, the equipment should be tested to determine process control limits, potential failure modes, action levels, and worst case scenarios.  

  • Performance Qualification (PQ) - In the performance qualification phase, the goal is to demonstrate that the process will consistently produce acceptable results under normal operating conditions.

It’s important to note that the phases of process validation must occur in this order: IQ, OQ, PQ. Logically, operational qualification cannot happen until the equipment has been installed correctly; nor can performance qualification happen until the equipment is operating.

 

What is installation qualification (IQ)?

Installation qualification answers the question: “Is everything installed correctly?”

Before you can test whether your equipment performs correctly, you need to know that it has been delivered, installed, and configured correctly. Installation qualification is the documented process that verifies equipment and any parts that comes with it against a checklist of specifications from the manufacturer.  

The following steps are often included in IQ: 

  • Cross-checking the contents of a package against the packing list

  • Checking for damage to the device 

  • Making sure each piece of equipment is installed in the proper location

  • Checking connections to other devices or equipment

  • Verifying the installation of any ancillary equipment

  • Verifying power supply to the device

  • Verifying that the operating conditions and environment match the manufacturer’s specifications

  • Recording calibration and the dates of validation for the equipment used in the IQ

  • Organizing the manuals, certificates, and any other necessary documentation.

What is operational qualification (OQ)?

Operational qualification answers the questions: “Is everything operating correctly?” and, “What are the operating limits of this device?”

Once the IQ has been conducted, the next stage in process validation—operational qualification—ensures that the equipment is operating in accordance with the user’s requirements and within the operating range specified by the device manufacturer. In other words, OQ makes sure that the medical device is functioning the way it was designed to. 

Operational qualification involves testing all the different functions of the equipment and establishing the operational parameters of the device, which may include:

  • Displays and operational signals, such as LEDs

  • Temperature fluctuation controls

  • Humidity measurement and control systems

  • Fan or motor RPM

  • Servo motors and air-flap controllers

  • Card access and reader

  • Timers and activity triggers

 

What is performance qualification (PQ)?

Performance qualification answers the questions: “Does this process produce the right result?” and, “Is this process safe and consistent?”

While similar to operational qualification, performance qualification is used to verify that the equipment consistently produces the correct results under real-world conditions. That means PQ should be conducted in the actual facility with trained personnel, using the utilities, equipment, control procedures and manufacturing process that will be used to produce commercial batches of the product.

Rather than testing individual components to ensure they are operating correctly, as in OQ, PQ tests the performance of a device as a whole to ensure a stable, repeatable production of the final product.

FDA recommends creating a written protocol for performance qualification that includes the following items:

  • The manufacturing conditions, operational parameters, and raw materials used. 

  • The data you will collect and the plan for evaluating it

  • The tests you will conduct on the equipment and the acceptance criteria for each

  • An extensive sampling plan that provides confidence of the quality within batches and between batches

  • The criteria for making science- and risk-based decisions about the efficacy of the process

  • The design of the facilities and personnel qualification and training

  • The validation status of the analytical methods used to measure the process, materials, and eventual product

  • The review and approval of the protocol by all relevant departments and the quality team

Once the protocol has been reviewed and approved, then PQ may begin. Afterward, the manufacturer should prepare a report assessing adherence to the protocol, summarizing the collected data, and addressing any manufacturing nonconformances.

BONUS RESOURCE: Click here to download this free Master Validation Plan (MVP) form to document a list of all of your company's processes that require validation.

Streamline your process validation with Intelligent Document Management from Greenlight Guru

IQ, OQ, and PQ all require strict adherence to process—and the proper documentation of that process. Manufacturers that rely on paper-based QMS tools often have trouble organizing and finding documents when they need them. 

That’s why our Medical Device Success Platform (MDSP) at Greenlight Guru uses Intelligent Document Management. Our MDSP was purpose-built for medical device companies, so we understand the importance of having your documents, records, and procedures organized, up-to-date and always accessible to the right people with role-based security.

Save time navigating through your quality system with the ability to see your document structure in a centralized view. Get your free demo of Greenlight Guru today!


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