How to Establish a GLP System
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GLP (Good Laboratory Practice)
How to establish a GLP system
The GLP (Good Laboratory Practice) system rests on the principles prepared by the Organisation for Economic Co-operation and Development (OECD) in 1980, which set out the requirements for handling chemical substances in laboratories. Those principles were reviewed in 1995 and 1996 to cover all laboratory research, and in 1998 they were implemented across disciplines as an internationally accepted management system. Applying every provision of the GLP guidance in practice requires solid laboratory management and a system that links everyday work to the written procedures.
On the regulatory side in Turkey, the Ministry of Health issued a Good Laboratory Practice guide in 1995, and the Ministry of Environment issued the regulation on Good Laboratory Practice principles and the certification of test laboratories in 2002.
The purpose of the GLP guide is to set the principles for coordinating, carrying out, monitoring, recording, and reporting the work of laboratories that collect information on environmental or human health, or that examine substances whose properties need to be determined.
The regulation on Good Laboratory Practice principles and the certification of test laboratories defines the rules for the principles themselves and for laboratory certification. Both regulations sit on the GLP system standards and the principles of a quality management system. For that reason, the most effective way to establish GLP in a laboratory and to integrate it with the quality management system is to take consultancy support. That path shortens the route to a system that operates to the defined standards.
Under the 2010 regulation on Good Laboratory Practice principles, harmonisation of test facilities, and the review of GLP activities and studies, TÜRKAK (the Turkish Accreditation Agency) is the National Monitoring Authority with legal competence over the compliance review.
How Sistem Patent Kalite supports GLP setup
The team works alongside the laboratory's management on the system design, the documentation, staff training, and the readiness audit before the TÜRKAK review. Clients avoid the trial-and-error period that usually follows a first GLP project and reach the compliance review with a functioning system.
