What is GLP?

What is GLP?

GLP (Good Laboratory Practice) is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. GLP ensures the quality and integrity of data from laboratory studies used to support regulatory submissions.

Simple Analogy: Think of GLP as a comprehensive audit trail for laboratory research. Just as a detective meticulously documents every piece of evidence to ensure it's admissible in court, GLP ensures every aspect of a laboratory study is documented, traceable, and reliable for regulatory decision-making.

Historical Context: GLP was developed in the 1970s following scandals where fraudulent toxicology data led to approval of unsafe products. The OECD established GLP principles in 1981, now adopted globally.

Key Focus: GLP applies to non-clinical studies (toxicology, pharmacology, environmental safety) that support regulatory submissions for pharmaceuticals, chemicals, pesticides, and medical devices.

Why is GLP Certification Important?

GLP (Good Laboratory Practice) is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. GLP ensures the quality and integrity of data from laboratory studies used to support regulatory submissions. Simple Analogy: Think of GLP as a comprehensive audit trail for laboratory research. Just as a detective meticulously documents every piece of evidence to ensure it's admissible in court, GLP ensures every aspect of a laboratory study is documented, traceable, and reliable for regulatory decision-making. Historical Context: GLP was developed in the 1970s following scandals where fraudulent toxicology data led to approval of unsafe products. The OECD established GLP principles in 1981, now adopted globally. Key Focus: GLP applies to non-clinical studies (toxicology, pharmacology, environmental safety) that support regulatory submissions for pharmaceuticals, chemicals, pesticides, and medical devices.

Key Principles

The framework is built on fundamental principles that guide implementation and ensure effectiveness:

Systematic Approach

Structured methodology for implementing and maintaining effective management systems.

Continuous Improvement

Ongoing monitoring, measurement, and enhancement of processes and performance.

Stakeholder Focus

Meeting the needs and expectations of customers, regulators, and other stakeholders.

Conclusion

GLP is the gold standard for non-clinical laboratory studies, ensuring data integrity and reliability for regulatory decision-making. While GLP implementation requires significant investment in infrastructure, personnel, and procedures, it's essential for laboratories conducting studies that support regulatory submissions.