Who Can Obtain a GLP System Certificate

Who can obtain a GLP System Certificate

A GLP (Good Laboratory Practice) System Certificate is available to laboratories that run non-clinical health and environmental safety studies. The system exists to secure the reliability and quality of test results, protect human health and the environment, and support mutual acceptance of data across countries. By removing the need for repeat testing, the system also saves time, resources, and cost, and supports the protection of laboratory animals.

The first to benefit are the laboratories that set the system up internally. The GLP framework is a quality assurance system that governs the coordination, monitoring, recording, archiving, and reporting of non-clinical health and environmental safety studies. Looking at the studies GLP is designed to govern, the types of laboratories eligible for a GLP System Certificate become clear.

• Laboratories that carry out non-clinical safety studies for pharmaceutical manufacturing
• Laboratories that develop biocides, the chemical substances used to control or eliminate harmful organisms in human living or working environments
• Laboratories that carry out safety studies
• Laboratories that develop agricultural pesticides used to prevent, control, or minimise the effects of harmful organisms
• Laboratories that work on toxic chemical substances, including substances considered medically toxic
• Laboratories that develop food additives
• Laboratories that carry out testing on substances with explosive properties
• Laboratories that develop cosmetic products

Test units within companies and independent laboratories that want to enter the GLP Compliance Monitoring Programme receive a GLP Compliance Statement once their practice aligns with the OECD Principles of Good Laboratory Practice. A company that wants a GLP System Certificate submits the OECD Good Laboratory Practice application form and supplies the supporting information and documents the authority requires.

How Sistem Patent Kalite supports the process

Sistem Patent Kalite handles both the system setup and the application. The service covers the documentation, staff training, internal audits, and the technical liaison with the authority, so the laboratory moves through the process with a single partner.