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Good Laboratory Practice

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Good Laboratory Practice

Principles of Good laboratory practice (GLP) is a quality system laying down organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. 

National GLP monitoring authorities assess compliance with GLP principles of all national test facilities conducting non-clinical health and environmental safety studies to be submitted to receiving authorities for the purposes of assessment of chemicals and other uses relating to the protection of man and the environment. 

Non-clinical studies may inter alia consist of testing physical and chemical properties of chemicals, toxicity, mutagenicity, ecotoxicity, bioaccumulation residues, and impacts on ecosystems as well as chemical analyses regarding such testing. GLP principles cover all test facility activities in laboratories, on animals, plants and in the fields that are performed in the framework of such studies.

The main aims of GLP are:

  • generating of high quality and reliable test data pertaining to protection of man and the environment in the area of chemicals, such as pharmaceuticals, veterinary  drugs, plant protection products, biocidal products, industrial chemicals, cosmetics, food and feed additives, and without prejudice against explanation and evaluation of study’s results, 
  • mutual acceptance of data  (MAD) of studies among countries so as to reduce a number of animal tests and lower costs of chemicals industry and those of monitoring/receiving authorities. 

GLP principles have been developed in the framework of OECD, and were first published in 1981. This was followed by publications of a series of documents relating to compliance monitoring. More data is available on OECD GLP internet site.
 
EU has transposed into its legislation OECD acts on MAD and GLP principles through Directives 2004/9/EC and 2004/10/EC. More relevant information is available on EU GLP internet site.

 
Test facilities wishing to join GLP compliance monitoring programme are liable to - pursuant to the Chemicals Act - submit an application to the Chemicals Office of the Republic of Slovenia to conduct compliance inspection. Chemicals Office of the Republic of Slovenia inspects test facility and decides on its compliance based on a inspection report. Inspections are made regularly every 2 years and are to be duly paid for.

Overview of test facilities in the Slovenian GLP compliance monitoring programme

Test facility Expertise Status Date first in inspection Date of last inspection Nature of inspection
KRKA d.d., Razvoj in raziskave, Šmarješka cesta 6, 8501 Novo mesto 1, 2, 8 IC 27. 8. 2001 November 2016 full
NIB, Oddelek za gensko toksikologijo inbiologijo raka, Večna pot 111, 1000 Ljubljana 2 IC 13. 7. 2015 October 2017 full

Legends and abbreviations used in the table:

Expertise: 1 - toxicity studies     2 - mutagenicity studies     8 - analytical and clinical chemistry testing

Status:     IC - in compliance, no or only minor deviations from the GLP principles have been observed

               PEN - pending, deviations from the GLP principles have been observed, monitoring procedure still in progress

               NIC - not in compliance, major deviations from the GLP principles have been observed, the reliability of data cannot be ensured

Nature of inspection: first- first inspection of new test facility      full- full routine inspection

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