What is the difference between ISO 17025 and Good Laboratory Practice?

When it comes to laboratory standards, two prominent ones that often come up in discussions are ISO 17025 and Good Laboratory Practice (GLP). Both of these standards are essential for ensuring reliable and high-quality testing and calibration results. However, they differ in their scope, requirements, and application. In this article, we will explore the key differences between ISO 17025 and GLP.

ISO 17025: The International Standard for Testing and Calibration Laboratories

ISO 17025 is an internationally recognized standard specifically developed for testing and calibration laboratories. It outlines general requirements for technical competence, impartiality, and consistent operation. This standard sets the criteria for competency in laboratory personnel, proper equipment calibration and maintenance, valid test methods, and accurate recording and reporting of results.

One of the distinctive features of ISO 17025 is its focus on the entire laboratory management system. This includes consideration of factors such as organizational structure, document control, records management, quality assurance, and continual improvement. ISO 17025 also emphasizes the importance of regular internal audits and participation in proficiency testing programs to ensure ongoing compliance and competence.

Good Laboratory Practice (GLP): Ensuring Integrity in Non-clinical Studies

Unlike ISO 17025, GLP is not specific to testing and calibration, but rather, it focuses on non-clinical studies. It sets forth principles and guidelines designed to ensure the quality, integrity, and reliability of data generated from safety assessments, environmental studies, and other non-clinical research involving chemicals and pharmaceuticals.

The main objective of GLP is to provide a framework for organizing and conducting studies in a way that minimizes errors, ensures traceability, and promotes good scientific practices. This involves factors such as appropriate study design, detailed protocols and standard operating procedures (SOPs), qualified personnel, appropriate facilities, and accurate documentation. GLP also emphasizes the importance of rigorous independent quality assurance audits.

Differences in Scope, Focus, and Application

While ISO 17025 and GLP share the common goal of ensuring quality and reliability in laboratory activities, there are notable differences between the two:

1. Scope: ISO 17025 focuses on testing and calibration laboratories, while GLP specifically applies to non-clinical studies.

2. Requirements: ISO 17025 sets general requirements for technical competence, impartiality, and consistent operation, whereas GLP provides guidelines for conducting non-clinical studies.

3. Management system: ISO 17025 emphasizes the entire laboratory management system, including elements like organizational structure, document control, records management, and proficiency testing participation. GLP focuses more on study design, protocols, SOPs, and independent quality assurance audits.

4. Application: ISO 17025 is applicable to any laboratory performing testing and calibration, regardless of the industry. GLP applies specifically to laboratories conducting non-clinical studies involving chemicals and pharmaceuticals.

In Conclusion

ISO 17025 and GLP are critical standards that contribute towards ensuring quality and reliability in laboratory testing and research. While ISO 17025 addresses the overall competency and management of testing and calibration laboratories, GLP focuses on specific practices for non-clinical studies. Understanding the difference between these two standards is crucial for organizations and professionals involved in laboratory activities, enabling them to align with the most relevant requirements for their specific field.