Infrastructure qualification is a critical process in ensuring that equipment, systems, and facilities are fit for their intended use in regulated industries, particularly in pharmaceuticals and biotechnology. The process involves rigorous testing, change control, and extensive documentation to meet compliance standards and ensure continuous improvement.  This blog will break down the stages of Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), highlighting the importance of each stage in achieving and maintaining a state of control.

Stages of Infrastructure Qualification

Installation Qualification (IQ)

Installation Qualification (IQ) is the first stage of the qualification process.  It ensures that all critical components of the infrastructure are installed correctly and according to the manufacturer’s specifications and in alignment with infrastructure design specifications.

Activities:

  • Verification of Installation: Check that the equipment is installed as per the installation plan and manufacturer’s guidelines.  This includes verifying the location, connections, and proper assembly of all components.
  • Documentation Review: Ensure that all necessary documentation, such as manuals, drawings, and certificates, is available and complete.
  • Calibration and Instrumentation: Verify that all instruments and control systems are calibrated and functioning correctly.
  • Environmental Conditions: Ensure that the installation environment (room temperature, humidity, cleanliness, and security) meets the specified requirements.

Importance: IQ provides the foundation for subsequent qualification stages by confirming that the infrastructure is correctly installed and ready for operational testing.  It ensures that any installation errors are identified and corrected early in the process.

Operational Qualification (OQ)

Operational Qualification (OQ) follows IQ and involves testing the infrastructure under live or simulated operational conditions to verify that it performs as intended.

 Activities:

  • Functionality Tests: Conduct tests to ensure that all functions of the equipment and systems operate as expected.  This includes verifying alarms, controls, and interlocks.
  • Process Simulations: Simulate real operational scenarios to test the performance and reliability of the infrastructure.  This should include failover tests (e.g device removal/shutdown, connection loss) and traffic rules)
  • Stress Testing: Test the system under various stress conditions to ensure it can handle extreme operational scenarios (e.g Bandwidth/throughput, latency, and packet loss during failover)
  • Software Verification: Validate any monitoring software or other automated management systems that are part of the infrastructure have the required access and function appropriately.

Importance: OQ ensures that the infrastructure operates correctly and consistently within the specified operational parameters.  It identifies potential operational issues before the system is used for actual production or service delivery.

Performance Qualification (PQ)

Performance Qualification (PQ) is the final stage of the qualification process.  It verifies that the infrastructure performs effectively and reproducibly in the actual production environment.

 Activities:

  • Process Performance Tests: Conduct tests using actual production materials and conditions to ensure that the infrastructure can consistently produce the desired output.
  • Extended Duration Testing: Perform tests over extended periods to verify long-term performance and reliability, either prior to or during System Validation.
  • Data Collection and Analysis: Collect and analyze data to confirm that the infrastructure meets all specified performance criteria.

Importance: PQ provides the final assurance that the infrastructure is fit for its intended use.  It confirms that the system can consistently produce results that meet predefined quality standards under normal operating conditions.

Integration with Change Control

Change control is an essential component of infrastructure qualification.  Integration is more than IT processes, it is a synergy and integration with the Quality Department, designed to hold IT accountable for deployment and decisions.  Additionally, it ensures that any changes to the infrastructure are evaluated, documented, and approved to maintain a state of control.  Types of Changes (e.g Standard, Minor, Major, and Emergency) should be defined and categorized in the Quality Management System (QMS) with appropriate workflows for each.

Key Elements of Change Control

  • Change Proposal: Document the proposed change, including its rationale and potential impact on the qualified state.
  • Impact Assessment: Evaluate the impact of the change on existing qualifications, including IQ, OQ, and PQ.
  • Approval Process: Obtain approval from IT management, relevant stakeholders, and should include quality assurance and regulatory compliance teams as a final signatory.
  • Implementation and Testing: Implement the change and conduct necessary testing to verify that the qualified state is maintained.
  • Documentation: Update all relevant documentation (training materials, SOPs, and job aides) to reflect the change and its impact.

Extensive Documentation

Extensive documentation is crucial for demonstrating compliance with regulatory requirements and maintaining a state of control.  It provides a detailed record of all qualification activities and ensures transparency and traceability.

Key Documents

  • Configuration and As-built Documentation: Documents the current configuration, connections, rules, IP addresses, and in use devices.  The documents should be controlled and treated as living documents for any change to any device as a verification of changes during audits.
  • Installation Qualification Protocol and Report: Documents the installation process and verifies that all components are installed correctly.
  • Operational Qualification Protocol and Report: Outlines the tests conducted during OQ and their results.
  • Performance Qualification Protocol and Report: Details the tests performed during PQ and their outcomes.
  • Change Control Records: Document all changes to the infrastructure and their impact on the qualification status.
  • Maintenance and Calibration Records: Track ongoing maintenance and calibration activities to ensure continued compliance.

Continuous Improvement

Continuous improvement is a fundamental principle in infrastructure qualification.  It involves regularly reviewing and updating qualification processes to enhance performance and compliance.

Strategies for Continuous Improvement

  • Periodic Review: Conduct regular reviews of qualification processes and documentation to identify areas for improvement.
  • Feedback Loop: Gather feedback from operational teams to identify issues and opportunities for enhancement.
  • Training and Development: Provide ongoing training for personnel involved in qualification activities to ensure they are up-to-date with best practices and regulatory requirements.
  • Technology Upgrades: Evaluate and implement new technologies that can improve the efficiency and effectiveness of qualification processes.

Conclusion

Infrastructure qualification is a comprehensive process that ensures systems and facilities are fit for their intended use.  By following the stages of IQ, OQ, and PQ, and integrating change control, testing, extensive documentation, and continuous improvement, organizations can maintain a state of control and compliance while still remaining agile to business needs. Assurea’s expertise in Infrastructure Qualification provides invaluable support to pharmaceutical companies, helping them achieve and maintain the highest standards of system reliability, compliance, and operational excellence. With Assurea’s guidance, companies can confidently navigate the complexities of infrastructure qualification, ensuring that their systems are always fit for use and capable of meeting the demands of a dynamic and highly regulated industry.