GLP-compliant or non-GLP-compliant?

Knowledge

We are often confronted with the question of what the difference is between GLP-compliant and non-GLP-compliant testing of medical devices and when GLP-compliant testing is useful or necessary. This question also has an economic background, as GLP-compliant tests cause additional costs. We would like to help you with these questions.

What is GLP?

Good Laboratory Practice (GLP) is a quality assurance system for test facilities that carry out non-clinical tests in the health and environmental sectors. GLP recognition enables the mutual recognition of tests conducted according to the principles of GLP by the regulatory authorities of OECD member states*. 
GLP-recognised test facilities are integrated into the national official GLP monitoring procedure and are regularly checked for compliance with the GLP principles in accordance with the Chemicals Act and 2004/9/EC by the responsible monitoring authorities.

GLP regulates the organisational processes and conditions under which non-clinical health and environmental studies are planned, conducted, monitored, recorded, archived and reported.

GLP-compliant testing is recommended when seeking approval of medical devices in the U.S. market (or in markets aligned with the U.S. FDA). The U.S. Food and Drug Administration (FDA) favours GLP-compliant testing because it ensures strict quality standards.

The decision as to whether the test should be GLP-compliant or non-GLP-compliant depends to a large extent on the market in which the products are to be authorised.

* Europe, USA, Canada, Japan, Mexico, Australia and others


Read more about this in our Knowledge article

 

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