The GLP System Certification Process

The GLP system certification process

The GLP (Good Laboratory Practice) certification path is set out in national regulation. In 2010, the Ministry of Environment and Forestry issued the regulation on Good Laboratory Practice principles, harmonisation of test facilities, and the review of GLP activities and studies. This is the framework that governs the certification a laboratory can obtain through Sistem Patent Kalite.

The GLP regulation covers laboratory studies on food additives, pharmaceutical products, cosmetic products, substances used to prevent, control, or eliminate harmful organisms, feed additives, industrial chemicals, and similar products tested for safety in humans and animals. It also applies to the coordination, recording, and reporting of those studies, including the review of the test conditions under which the studies take place.

The regulation authorises the National GLP Monitoring Authority to review whether the activities of test units within companies, or of laboratories established specifically for such work, match the GLP system standards, and to restrict or withdraw a previously issued compliance statement. Compliance reviews are carried out under the national monitoring programme prepared by the Authority. The same regulation confirms the legal competence of the designated bodies to act as the National GLP Monitoring Authority.

Test units of companies and independent laboratories that want to enter the GLP Compliance Monitoring Programme are reviewed against the OECD Principles of Good Laboratory Practice by the competent authority. Where the review is positive, a Good Laboratory Practice Compliance Statement is issued. A company that wants a GLP System Certificate applies through the Good Laboratory Practice application form and submits the supporting information and documents the Authority requires.

How Sistem Patent Kalite supports the certification

Sistem Patent Kalite prepares the dossier, aligns the laboratory's practice to the OECD principles, and manages the interaction with the monitoring authority through to the compliance statement. Clients receive a single contact, a clear timeline, and practical guidance on closing findings.