In FDA-regulated industries, there are a variety of standardized qualifications that a product must meet post-manufacture. In the Life Sciences industry, that means medical devices go through a series of qualification testings to ensure safe operation for providers and patients. 

There are three qualification tiers used to evaluate the various manufacturing stages for medical devices: IQ, OQ, and PQ. Each of these quality assurance processes is meant to ensure consistency in the manufacturing and production of medical devices and consumer safety when using these devices. We explain each below as well as how we can help you successfully navigate FDA regulation processes.  

IQ = Installation Qualification 

Installation qualification (IQ) checks that all parts of a medical device have been delivered, installed, and put together according to industry and device-specific standards. This qualification tier assesses the stability and performance of medical devices and seeks to minimize discrepancies in post-manufacture and pre-operational stages. 

To assess installation, IQ evaluators refer to design and system specifications, developers’ and manufacturers’ recommendations, and other datasheets. As part of the user requirements and design phases, functional specifications, engineering drawings and piping/instrument diagrams (P&ID) are generated. IQ assessors subsequently use these documents as standards for evaluating installation. 

IQ often involves checks and evaluations of the following aspects of installation: 

  • Location/placement
  • Adherence to the packing list
  • Electrical supply
  • Signals and alarms
  • Internal software
  • Standard operating procedures
  • Installation process

If your medical device is in the post-manufacture and pre-operational stages, it is a good idea to bring in an expert to walk you through the IQ evaluation procedure. Read more about our FDA Compliance Services to better understand how an FDA compliance expert can help you through this process.  

OQ = Operational Qualification 

Operational qualification (OQ) checks that all components of a medical device are operating appropriately and as intended when done so in accordance with manufacturer-approved ranges. 

The OQ testing process involves identifying critical operating parameters and conducting experiments on critical variables. These steps should include documentation of details about the experiments, the measuring equipment, and guagable criteria for the device’s proper operation. This analysis is meant to be conducted following initial installation, after any major maintenance or modification, and during quality assurance testing.  

OQ often involves checks and evaluations of the following: 

  • Alarms
  • Pressure
  • Speed
  • Timing
  • Voltage 
  • Controls
  • Interlocks

OQ is the one tier of these assessments that is meant to occur somewhat regularly on the same device. With that in mind, it is important to maintain medical devices at their optimum operational levels, consistently ensuring that all major components are functional and well cared for.  

PQ = Performance Qualification

Performance qualification (PQ) checks that all aspects of a medical device operate as intended. This testing aims to verify that all parts of the device can function at their operational capacities. Essentially, PQ seeks to identify how the device actually works in an everyday setting. 

There are a variety of parts and steps involved in PQ testing, which include adherence to established criteria, rationale for data collected and tools used to do so, operational protocols for personnel, and a sample plan, among other things. Some of the issues that might be identified during PQ testing include pressure concerns, overheating, excessive vibration, and prohibitive noise levels. This phase of testing often involves testing the device’s calibration and variability limits. 

The FDA breaks PQ testing into two evaluative parts:

  • Facility design & equipment qualifications
  • Process performance qualification (PPQ)

This qualification tier includes a significant amount of planning and documentation that must be completed in a clear, justified, and comprehensive manner. Having a general idea of how the FDA approaches PQ testing will better prepare you for the process. 

Need help with FDA compliance?

In summary, IQ, OQ, and PQ are quality assurance protocols regulated by the FDA that ensure medical devices that reach the consumer are meeting quality standards and providing consistent operational performance. Additionally, the documentation required as part of these qualifications assists manufacturers in streamlining and simplifying identification and address of device issues.   

While these qualification processes might sound overwhelming, Premier FDA can make FDA compliance more manageable and streamlined. We are here to help your Life Sciences manufacturing and other operations the best they can be. Contact Premier FDA to get FDA ready today