IQ, OQ, PQ: Your essential guide to Process Validation

Failure in a manufacturing process of medical devices can lead to devastating consequences for patients. Ensuring proper process validation when manufacturing medical devices therefore is one of the key regulatory requirements. The US FDA as well as ISO 13485 requires manufacturers to implement ways to ensure the produced devices meet the documented design specifications. 

This can be done through post-production testing. However, it's not always possible to test each single product and testing itself might even destroy the product. This is where process validation comes into play. IQ, OQ and PQ are quite common abbreviations used when talking about process validation. In this article we go deeper into what they mean and how these principles are translated into the medical device industry.

What is Process validation?

Process validation is a key aspect of ensuring that medical devices are manufactured according to the predefined specifications by focusing on the process rather than validating the device itself.

One of the methodologies used are IQ, OQ and PQ protocols. Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are a crucial part for both hardware and software components in medical device manufacturing.

According to the 21 CFR Part 820 section 820.75, FDA requires: "Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented."

ISO 13485:2016 requires that "The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement." It also requires to validate software that is used in the QMS. Regarding this topic specifically, we refer to one of our previous articles. 

Neither give detailed instruction on how to perform these validations.

What is IQ, OQ, PQ?

Installation Qualification (IQ)

Installation Qualification (IQ) for hardware verifies that the physical equipment and ancillary systems are installed correctly and in accordance with manufacturer specifications and regulatory requirements. It ensures that all components of the hardware are received as designed and that it is properly installed in the intended environment.

As you're thinking about Installation Qualification (IQ) some key elements to consider:

• Have you received everything? Is the delivery complete according to the packing list?

• Is everything delivered in good shape? Are there no damaged parts?

• Has everything been installed in the proper location?

• Are connections with other equipment or devices done correctly?

• Is the power supply (if any) working correctly?

• Are the operating conditions and the environment according to the manufacturer's specifications?

• Has a software compatibility check been performed?

• Are user access and security settings configured correctly?

• Has a software functionality test been performed?

• Is the network connectivity and configuration been verified?

• Is all documentation received and stored properly (i.e. manuals, certificates, etc)?

• Are there calibration records with validity dates?

Installation Qualification (IQ) for software focuses on verifying that the software is correctly installed and configured according to specifications. It includes ensuring proper installation of software components, validation of licenses, and confirmation of compatibility with the hardware and operating system.

Operational Qualification (OQ)

After the IQ has been completed, the Operational Qualification (OQ) phase can start. OQ for hardware focuses on ensuring that the equipment operates according to its operational specifications within predetermined limits. This involves testing the hardware under various operating conditions to verify its functionality, accuracy, and reliability. 

Operational Qualification (OQ) for software involves testing the software to ensure that it performs its intended functions accurately and reliably under normal operating conditions. This may include testing user interfaces, data input/output, error handling, and system performance.

Performance Qualification (PQ)

While similar to OQ, Performance Qualification (PQ) for hardware evaluates the ability of the equipment to consistently produce results that meet predetermined acceptance criteria under real-world conditions. PQ tests are conducted under actual working conditions to demonstrate that the hardware performs reliably and consistently over time. This means that this part of the process validation is done in the actual facility, with trained personnel, using all tools, equipment and procedures that will be used in the manufacturing of commercial products.

Aspects to consider when thinking about a PQ protocol are:

• What are the actual manufacturing conditions? What are the operational conditions? Are we using the same setup and materials? 

• Which data will we collect and how will that data be evaluated?

• What are the acceptance criteria?

• What is the sampling plan? How can we ensure batch to batch consistency?

• What are the criteria for evaluating the process?

• What is needed in terms of facilty and training of personnel?

Performance Qualification (PQ) for software evaluates the ability of the software to consistently produce results that meet predetermined acceptance criteria. This involves testing the software under various conditions to ensure that it performs reliably and consistently over time, including scalability, data integrity, and compliance with regulatory requirements.

When do you use IQ, OQ and PQ?

IQ, OQ, and PQ protocols are typically employed during the initial qualification of new hardware or software components, as well as during equipment upgrades, relocations, or significant maintenance activities. These protocols are also utilized when implementing new processes or making significant changes to existing ones that may impact the performance of the hardware or software.

Why are IQ, OQ, and PQ so important in medical device manufacturing?

Ensuring the quality, safety, and efficacy of both hardware and software components in medical devices is critical to safeguarding patient health and meeting regulatory requirements. IQ, OQ, and PQ protocols provide a systematic approach to validating hardware and software, helping to identify and mitigate potential risks and ensuring consistent product quality. Compliance with these protocols is essential for obtaining regulatory approvals and maintaining the trust of patients, healthcare providers, and regulatory authorities.

How to execute an IQ OQ or PQ protocol?

Executing an IQ, OQ, or PQ protocol for hardware and software involves meticulous planning, documentation, and execution. It typically begins with the development of a protocol that outlines the specific tests and acceptance criteria to be followed. The protocol should be executed by trained personnel following standard operating procedures and using calibrated equipment or software tools. Upon completion of the testing, comprehensive documentation of the results, deviations, and corrective actions is required to demonstrate compliance with regulatory requirements.

Using Matrix Requirements to get your medical device compliant

Process validation is an important part of your QMS. If you want to explore how Matrix can help you building a compliant QMS and reduce your time on paperwork, don't hesitate to book a demo!