GOOD LABORATORY PRACTICE

 

Good laboratory practice (GLP) is a quality system laying down organization, procedures and requirements to plan, implement, document, archive and transfer of non-clinical studies and their results.

 

Relevant national monitoring authorities evaluate compliance and consistency with GLP principles of all national facilities conducting non-clinical health and environment safety studies on chemicals with the aim of applying procedures for their trade and use, as well as for registration and application procedures.

 

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

GLP aims at:

  • securing efforts to generate high quality and reliable data pertaining to protection of man and the environment against various sorts of chemicals, such as pharmaceuticals, veterinary  drug products, 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 test and trim costs of chemicals manufacturers and those of monitoring 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 at

 http://www.oecd.org/countries/argentina/goodlaboratorypracticeglp.htmhttp://www.oecd.org/topic/0,2686,en_2649_34381_1_1_1_1_37465,00.html.
 
The 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 at

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/laboratory-practice/index_en.htmhttp://ec.europa.eu/enterprise/chemicals/legislation/glp/index_en.htm.
 
Test facilities wishing to join GLP compliance monitoring are liable to - pursuant to the Chemicals Act - submit an application to the Chemicals Office of the Republic of Slovenia to conduct compliance evaluation. The Chemicals Office of the Republic of Slovenia reviews such test facility and decides on its compliance based on a review report. Reviews are made regularly every 2 years, and are to be duly paid for.

 

 

 

 

OVERVIEW OF ALL TEST FACILITIES IN THE SLOVENIAN GLP COMPLIANCE MONITORING PROGRAM

Test facility

Expertise

Status

Date first in

compliance

Date of last

inspection

Nature of

inspection

KRKA, d.d.

Razvoj in raziskave

Šmarješka cesta 6

8501Novo Mesto

1, 2, 8

IC

27. 8. 2001

 

november 2013

 

full

LEK d.d.

Razvojni center Slovenija

Verovškova 57

1526 Ljubljana

1

IC

5.8. 2005

november 2012

full

 

 

  

Legends and abbreviations used in the tables:

 

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