Good Laboratory Practice (GLP) is a formal framework for safet y testing of products such as pharmaceuticals, chemicals and pesticides. It is part of the EU directives and anchored in the Chemicals Act in Germany. GLP defines clear procedures and requirements for the documentation and reporting of tests in order to ensure the quality and reliability of tests and to protect human and environmental health. The compliance with GLP standards is monitored by authorities and industrial companies.
GLP is important to ensure the quality and reliability of safety testing of products such as pharmaceuticals, chemicals and pesticides. Compliance with GLP standards is an important part of quality assurance and also plays a major role in product approval procedures. Companies must adhere to the GLP standards in order to obtain approval for their products. The authorities monitor the application of GLP to ensure that the tests are carried out correctly and reliably.
The definition of Good Laboratory Practice (GLP) according to the GLP principles of the Organization for Economic Co-operation and Development (OECD) states that GLP is a quality assurance system that focuses on the organizational procedures and framework under which non-clinical safety tests of relevance to health and the environment are performed, monitored and documented.
It is important to note that GLP inspections are mutually recognized, unlike GMP inspections. In addition, quality testing of APIs and medicinal products does not take place under GLP rules, but under GMP conditions.
The GLP Federal Agency gives the following reasons: Good Laboratory Practice has made an enormous contribution to health, environmental and animal protection through its worldwide implementation and the extensive mutual recognition of test data. Thanks to the mutual recognition of GLP implementation, multinational companies can, for example, save up to 70 percent of animal testing.
