GLP-INSPECTION
DANAK performs GLP compliance monitoring (or GLP inspections) at companies carrying out non-clinical health and environmental safety studies with regard to industrial chemicals, pesticide and biocide products, food and feed additives, cosmetic products and other products such as detergents.
GLP inspection of companies carrying out GLP studies is performed in accordance with OECD principles of good laboratory practice (GLP).
By good laboratory practice is meant procedures and conditions under which laboratory studies are planned, performed, monitored, recorded, reported and archived in accordance with the OECD principles of GLP. The purpose of GLP is to promote the development of quality data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries.
GLP compliance monitoring of test facilities or test sites is carried out periodically with the purpose of verifying the companies’ adherence to GLP principles.
GLP requirements are connected to regulatory requirements for the relevant product type.
REQUIREMENTS FOR GLP
The DANAK GLP-system is regulated by the following two executive orders:
- Executive Order No. 1389 of 25. november 2015 on the application and control of principles of good laboratory practice (GLP) for chemical substances and mixtures and GLP inspection, as well as the fees, can be downloaded here.
- Executive Order No. 805 of 22. june 2017 on application and control of principles of good laboratory practice (GLP) for food, as well as the fees, can be downloaded here.
the Danish Medicines Agency is referred to when carrying out GLP tests concerning medicinal products and veterinary medicinal products.
See the OECD guidelines regarding GLP here.
Companies that perform tests in accordance with the GLP regulations: See the list here
Fees for GLP according to the Danish Environmental Protection agency here (Danish text).
Download application form here.
Contact: Lead assessor Kirsten Marie Rosenberg, DANAK. Tlf: 7733 9583. E-mail: kmr@danak.dk.