Ensuring and certifying quality and compliance in regulated environments

26. 2. 2024

Článek

In regulated laboratories (e.g., food and pharmaceuticals), adherence to analytical requirements is a must. Implementing and utilizing lab instruments in these settings is not merely a routine procedure – it is a process that demands the highest standards of reliability and traceability. This is where Instrument Qualification and Operational Qualification («IQ/OQ») come into play. IQ/OQ ensures that analytical instruments produce reliable and meaningful results while maintaining compliance with regulatory standards.

Illustration of the concept of compliance: rules, standards, policies, requirements, regulations, transparency, and law.

Evolving with changing requirements

With decades of experience in commissioning instruments for regulated laboratories, we at Metrohm consistently uphold our commitment to robust IQ/OQ processes. Regulatory requirements continue to evolve and become more stringent. Accordingly, we have committed to providing our customers with best-in-class qualification procedures and documentation. We regularly use third-party, non-biased assessments to evaluate our software systems.

The Association of Official Analytical Collaboration International (AOAC INTERNATIONAL) publishes regulatory standards for food safety testing according to strict requirements. When AOAC INTERNATIONAL launched its certification program «Installation & Operational Qualification (Q²)» to evaluate and certify IQ/OQ documents and procedures, we eagerly accepted the opportunity to test our approach.

Embracing AOAC's Installation & Operational Qualification (Q²) certification program was a significant milestone in our journey towards excellence in IQ/OQ procedures. This initiative was designed to evaluate and certify IQ/OQ documents and procedures—a crucial aspect of Analytical Instrument Qualification.

For more information about Analytical Instrument Qualification (AIQ), read our two-part blog series here.

Introduction to Analytical Instrument Qualification – Part 1

Introduction to Analytical Instrument Qualification – Part 2

The outcome of this review by the AOAC SME was outstanding. Not only did Metrohm receive the first Q² Certificate issued under the program, the documents and procedures provided to AOAC are now recognized as a gold standard for future assessments.

This achievement is a testament to our dedication to excellence in instrument qualification and operational procedures, setting a high bar for the industry.

Benefits of the AOAC Q² program

The full meaning of this certification goes beyond praise and a title. Laboratories in regulated sectors can now benefit from a higher level of confidence in their choice of Metrohm as a partner for their analytical instruments.

Metrohm’s Q²-certified documents and procedures offer evidence that our IQ/OQ covers not just the essential aspects of qualification but also the preinstallation preparation and initial familiarization training. This ensures that every aspect of the instrument’s deployment and operation is meticulously addressed.

This certification significantly reduces the likelihood of rework, repeat testing, or negative consequences stemming from performance-related issues. In an environment where precision and reliability are critical, Metrohm's Q²-certified instruments provide peace of mind by simplifying the process of meeting regulatory requirements.

Portrait of technologist or worker in sterile white clothing standing by automated industrial machine in pharmaceutical company or factory.

Conclusion

The role of Instrument Qualification and Operational Qualification (IQ/OQ) is not only here to stay but will continue to evolve. Decades of experience in IQ/OQ do not exclude Metrohm from the important exercise of peer review. The AOAC Q² program provides a great platform to subject our documents, processes, and technical content to third-party review which ensures that we are keeping pace with (and setting) the gold standard in the industry.