A Basic Guide to IQ, OQ, PQ in FDA-Regulated Industries

In the highly-regulated pharmaceutical, medical devices, and clinical industries, even tiny inconsistencies can compound to serious issues without the proper qualification and validation protocols in place.

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

This quick-guide offers a clear and simple explanation of what these concepts are, why they’re important, what makes them successful, and a model for connecting with professionals who can plan and execute these types of projects.

If you’re planning a validation project, be sure to grab our free guide. Inside, you’ll find seven essentials to building an efficient and effective validation team along with expert insights from staffing professionals who routinely help life science organizations build successful project teams.

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What is IQ, OQ, 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.

Since these concepts are complex, it’s best to understand them one-by-one.

Installation Qualification (IQ)

Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results through Design Qualification (DQ)—a protocol defined as the documented verification of a proposed design’s ability to meet the requirements it needs to fulfill.

But how a particular unit of hardware or software performs in real-world scenarios depends on the installation procedure. Installation Qualification (IQ) verifies than an instrument or unit of equipment being qualified (as well as its sub-systems and any ancillary systems) have been installed and configured according to the manufacturer’s specifications or installation checklist.

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.

Regardless of whether it’s a physical unit or software being tested, the FDA’s IQ definition offers a useful statement of the overall goal: documenting that the “system has the necessary prerequisite conditions to function as expected.” 

Along with this, any CGMP requirements relevant to the IQ—and the methodology used for IQ—must be documented thoroughly in the Validation Master Plan (VMP).

 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.

What makes IQ successful?

Successful IQ is typically measured by how well the installation process followed the manufacturer's guidelines and met their requirements.

This often includes (but is not limited to) the following areas of focus:

  •  Location of install and necessary floor space
  • Documentation any and all computer-controlled instrumentation
  • Gathering all manuals and certifications
  • Properly unpacking and cross-checking instruments
  • Examining instruments and components for damage
  • Ensuring correct power supply
  • Installing ancillary instruments
  • Documenting firmware versions and serial numbers
  • Environmental and operating conditions
  • Checking software system installation and accessibility
  • Recording calibration and validation dates of tools used for IQ
  • Verifying connections and communication with peripheral units

Operational Qualification (OQ) 

Operational qualification (OQ) is performed after meeting each protocol of IQ. OQ’s purpose is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges. In action, this means identifying and inspecting equipment features that can impact final product quality.

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.

Read also: 5 Steps to Creating an Effective Life Science Validation Team

In general, OQ serves as a detailed review of hardware or software startup, operation, maintenance, cleaning and safety procedures (if and where they’re applicable). Every unit of hardware and software must be shown to be operating within the specified limits.

What makes OQ successful? 

As we explained above, the action items of OQ are identifying and inspecting the components of equipment that impact product quality and ensuring they’re operating within specific limits.

These often include (but, again, are no way limited to) the following:

  • Temperature control and variations
  • Servo motors and air flaps
  • Temperature protection systems
  • Card readers and access systems
  • Pressure and vacuum controllers
  • Temperature distribution
  • Display units and signaling LEDs
  • CO2 controls
  • Humidity-measuring and control
  • Fan and fan-speed controllers

Performance Qualification (PQ)

The final step of qualifying equipment is PQ. In this phase, the qualification and validation team verifies and documents that the equipment is working with reproducible results within a specific working range in simulated real-world conditions.

Instead of testing components and instruments one-by-one, PQ tests them all as a partial or overall process. 

Before they start qualifying, however, the team must create a detailed test plan based on the process description. It’s important to note that the quality of the qualification depends in large part on the quality of the test plan. This is one area where a third-party specialist can (and often should) be brought in to ensure thoroughness and accuracy.

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.

FDA Criteria for PQ and PPQ Protocols

In its guidance, “Process Validation: General Principles and Practices,” the FDA officially defines the PQ stage into its two elements:

  1. Design of the facility and qualification of the equipment and utilities
  2. Process Performance Qualification (PPQ)

During the second stage, the FDA states in its guidance that “CGMP-compliant procedures must be followed,” adding that “successful completion of Stage 2 is necessary before commercial distribution.”

The FDA guidance recommends including the following elements as part of PQ and PPQ protocols:

  • Manufacturing conditions such as equipment limits, operating parameters and component inputs
  • A thorough list of the data that should be recorded or analyzed during tests, calibration, and validation
  • Tests to ensure consistent quality throughout production
  • A sampling plan detailing the sampling methods used during and in between production batches
  • Analysis methodology for making data, scientific and risk-oriented decisions based on statistical data
  • Definitions for variability limits and contingency plans for handling non-conformance
  • Approval of the PPQ protocol by relevant departments—namely the Quality Unit.

More details on specific FDA expectations for PQ and PPQ can be found in the guidance document here.

An Effective, Cost-Efficient Model for Accessing Qualification & Validation Services

For most organizations, equipment qualification and validation is not a constant need, so performing it in-house is seldom feasible. 

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

This arrangement brings a number of advantages to quality departments and hiring managers:

  • Providing access to qualified personnel in an increasingly competitive labor environment
  • Freeing up time and attention within your internal teams
  • Reducing the costs of recruiting, screening, and onboarding staff

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.

Learn more about this, and other engagement models we utilize to help thousands of life science companies get the QA, RA, Clinical Operations, Qualification and Validation, and Manufacturing and Engineering resource and project support they need—where and when they need it:

Qualification & Validation Services:

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? Contact us today to connect with perfect-match resources supported by a Total Quality Guarantee.


Preparing for a Life Science Validation Project

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Topics: GxP, Validation