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IQ, OQ, and PQ: What are they and why are they important?

In any regulated manufacturing sector like biotechnology, medical services, pharmaceuticals, or chemicals, equipment and processes must meet predefined standards and requirements. To achieve this, manufacturers employ the three essential validation phases known as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Installation qualification (IQ)

The installation qualification phase is the initial step in the validation process. It entails the verification and documentation of the correct installation of systems, facilities, and equipment in alignment with predefined specifications and manufacturer guidelines. During this phase, the focus is on establishing the groundwork for optimal functionality and promptly identifying and resolving any installation errors that may arise.

Key components of the installation qualification phase

The key components of the IQ phase include physical verification, documentation review, and environmental requirements.

  • Physical verification. Equipment is inspected to validate its presence, serial numbers, and labels. This happens in the IQ phase to ensure that all necessary accessories, components, and utilities are in place.
  • Documentation review. Equipment documentation is reviewed, including user manuals, technical specifications, and drawings. This ensures that installations adhere to the provided instructions.
  • Environmental requirements. It must be verified that the installation environment meets required specifications for humidity, temperature, and ventilation, as well as for electrical requirements.
Person creating digital flowchart and diagrams

Why is the IQ phase required?

The IQ phase confirms that all equipment is installed correctly and is in line with the intended design and specifications. The IQ phase identifies and rectifies installation errors, ensuring regulatory compliance while demonstrating a commitment to quality and safety. It also lays a foundation that ensures that subsequent qualification phases are performed correctly and reliably.

IQ, OQ, and PQ: Develoop a comprehensive plan for the installation qualification process

Best practices for IQ implementation

It’s critical to develop a comprehensive plan for the installation qualification process, outlining your objectives, scope, and timeline. Identify your equipment and review the manufacturer’s guidelines, technical specifications, and regulatory requirements. Other best practices for this phase include:

  • Create detailed installation procedures with clear instructions for the handling, positioning, connection, calibration, and configuration of components. Conduct thorough verification, including visual inspections, functional testing, and measurement verification. Maintain accurate documentation of dates, serial numbers, personnel, deviations, and corrective actions.
  • Establish a process for addressing deviations or non-conformities encountered during the IQ phase. Document and investigate discrepancies, determine root causes, and implement corrective actions. Comprehensively train your installation team about procedures, safety, and equipment handling. Verify their skills and knowledge.

Operational qualification (OQ)

After the successful completion of the IQ phase, the next phase is operational qualification (OQ). During this phase, you’ll conduct tests to ensure that the equipment and systems function correctly and reliably under normal operating conditions.

Key components of the OQ phase

The key components of the OQ phase include testing equipment system functions, performance testing, and environmental testing.

  • Testing equipment system functions. During this phase, you’ll test various operations and functions of your equipment and systems to confirm that they operate as intended. Some of these tests may include mechanical, electrical, and software-based tests.
  • Performance testing. Test the equipment’s ability to perform under different operating conditions and scenarios. This may involve testing the equipment’s ability to handle workload capacity, response times, accuracy, precision, and stability.
  • Environmental testing. Assess equipment or system performance under different environmental conditions, such as temperature, humidity, vibration, or electromagnetic interference. Environmental testing helps determine if the equipment or system can operate reliably in various real-world scenarios.

Why is the OQ phase required?

The OQ phase verifies that equipment functions correctly, meets performance specifications, and operates reliably under normal operating conditions. This validation phase is paramount to ensure that equipment or systems can consistently deliver intended functionality.

Best practices for OQ implementation

Develop a comprehensive test plan that simulates real-world conditions, accounting for variables such as changing load, temperature, and unique user input. This ensures the accurate reflection of equipment performance. Other best practices include:

  • Maintain meticulous documentation of measurements, observations, and testing variations, noting both anticipated and actual results. Accurate record-keeping enables traceability and identifies areas for improvement.
  • Dedicate adequate time and attention to testing the equipment’s alarm systems and error-handling procedures. Verify the proper functioning of alarms, comprehensibility of error messages, and appropriate responses to deviations or defects. This testing ensures that the equipment is dependable and supports a secure working environment.

Performance qualification (PQ)

The performance qualification phase is the final step in the validation process. This phase ensures that equipment and systems consistently perform at levels that meet predefined requirements and specifications.

Key components of the PQ Phase

The main elements of the PQ phase include the following consistency and reproducibility, training and documentation, and data traceability and integrity.

  • Consistency and reproducibility. To ensure consistency and reproducibility, this step entails testing the system and equipment’s performance over an extended period of time. You’ll need to assess the performance under typical operating circumstances as well as worst-case scenarios.
  • Training and documentation. Create thorough and accurate documentation in the form of standard operating procedures (SOPs) and maintenance manuals, available to all users of the equipment.
  • Traceability and integrity of data. The PQ phase supports data traceability and integrity by incorporating data backup, archiving, and audit trails.
IQ, OQ, and PQ: The PQ phase ensures continuous compliance

Why is the PQ phase required?

The PQ phase ensures that equipment and systems continuously comply with predetermined specifications and standards. It evaluates equipment performance to ensure reliability, adherence to process parameters, and overall dependability. In addition, it provides recorded proof of compliance and reduces risks by identifying and correcting problems and minimizing failures and deviations. It guarantees that the machinery performs consistently and accurately over an extended period of time, proving that it’s suitable for the intended use.

Best practices for PQ implementation

Develop a comprehensive PQ protocol that includes clear goals, structured testing techniques, and well-defined performance parameters. Ensure that performance requirements align with legal constraints, business norms, and user expectations. Other best practices include:

  • Use representative test specimens or materials that accurately reflect the equipment’s expected usage, including its traits, variability, and challenges. Conduct extensive testing, including worst-case scenarios and various relevant process factors.
  • Maintain meticulous documentation of test information, including measurements, observations, and deviations. Perform a thorough analysis of gathered data, comparing equipment performance to predetermined requirements and acceptance criteria. Identify trends, patterns, and potential areas for improvement or further investigation.

What’s the difference between IQ, OQ, and PQ validation?

IQ, OQ, and PQ stages are distinct steps in the equipment validation process. Each ensures the equipment’s dependability, functioning, and adherence to legal requirements in its own way. The key differences are in their specific objectives within that process.

  • IQ ensures that equipment is installed properly, all the necessary parts are present, and each meets specifications. Lay the groundwork for further validation operations during this stage.
  • OQ checks the functionality of the equipment under typical operating circumstances. It guarantees that the machinery performs dependably and in compliance with operating specifications. Prepare the equipment for use by conducting OQ testing, which identifies and corrects any deviations.
  • PQ tests an item’s durability over an extended period of time to confirm its ability to reliably deliver the desired results within predetermined process parameters. PQ verifies that the machinery consistently and reliably complies with predetermined standards, assuring compliance and upholding product quality.

Conclusion

Organizations can ensure equipment and systems’ dependability, compliance, and performance by conducting these three validation processes. The methodical and thorough approach of IQ, OQ, and PQ helps with risk mitigation, process optimization, and product quality assurance to enhance operational effectiveness, client satisfaction, and regulatory compliance.

Check out Tricentis Vera™, a tool that will help you to enable compliance with 21 CFR Part 11 and other regulations.

This post was written by Theophilus Onyejiaku. Theophilus has over 5 years of experience as data scientist and a machine learning engineer. He has garnered expertise in the field of Data Science, Machine Learning, Computer Vision, Deep learning, Object Detection, Model Development and Deployment. He has written well over 660+ articles in the aforementioned fields, python programming, data analytics and so much more.

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