Analytical Instrument Validation According to Food Safety Management System (ISO 22000)

Importance of the Topic

The integrity of analytical measurements plays a pivotal role in verifying food safety across complex supply chains.
By applying ISO 22000 principles to instrument validation, laboratories can ensure data accuracy, enhance traceability, and strengthen consumer trust.

Study Objectives and Overview

This technical report outlines how ISO 22000 requirements interface with analytical instrument management and validation.
It examines the link between ISO 22000, HACCP, and ISO 9001, and presents a lifecycle model for instrument qualification from purchase to routine operation.

Methodology and Instrumentation

A phased approach is proposed for analytical system validation:

• Pre-purchase evaluation of user requirements and vendor capabilities.
• Installation Qualification (IQ) to confirm correct setup.
• Operational Qualification (OQ) to verify performance under defined conditions.
• Ongoing performance checks and software integrity tests.

Instrument and software validation adhere to sub-clause 8.3 of ISO 22000, covering calibration, verification, adjustment safeguards, and record-keeping.

Instrumentation Used

• LCMS-2010EV single quadrupole mass spectrometer with LCMSsolution control software.
• LC-20AD solvent delivery pump for flow stability assessments.
• Computer system integrating instrument control and data processing.

Key Findings and Discussion

• Treating the instrument and its controlling PC as one computer system simplifies validation.
• Software alteration checks, pump pulsation tests, and autotuning procedures demonstrated reproducibility within defined criteria.
• Clear division of responsibilities between user and vendor optimizes the validation workflow.

Benefits and Practical Applications

• Validated instruments deliver consistent and defensible analytical results for regulatory audits.
• Structured IQ/OQ protocols reduce downtime and support preventive maintenance.
• Traceable calibration and verification records enhance quality assurance and continuous improvement efforts.

Future Trends and Potential Applications

• Integration of real-time remote monitoring and automated alerts for instrument performance.
• Adoption of digital validation records within electronic quality management systems.
• Expansion of risk-based analytics and predictive maintenance through machine learning.

Conclusion

Systematic validation of analytical instruments under ISO 22000 strengthens food safety management by ensuring measurement reliability and supporting continuous improvement.
By formalizing qualification stages and leveraging vendor expertise, organizations can maintain high data quality and regulatory compliance.

References

• ISO 22000:2005 Food Safety Management Systems – Requirements for any organization in the food chain
• ISO 9001:2000 Quality Management Systems – Requirements
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• ISPE/GAMP Good Automated Manufacturing Practice Guides (GAMP4 and GAMP Good Practice Guide for Laboratory Systems)