Accreditation according to the principles of Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP)
The principles of Good Laboratory Practice (GLP) are a quality system regarding the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported.
GLP principles apply to non-clinical trials of test items contained in pharmaceuticals, pesticides, cosmetic products, veterinary medicines as well as food additives, animal feed additives and industrial chemicals. These test items are usually synthetic chemical compounds but may also be of natural or biological origin and in some cases living organisms. The purpose of testing these test items is to determine their properties and/or safety with regard to human health and / or the environment.
The principles of Good Laboratory Practice developed by the OECD Council in 1981 were revised in 1995 in order to adapt them to scientific and technical progress and adopted by the OECD Council on 26 November 1997 in accordance with decision (C (97) 186/Final). From this publication emerged the OECD monographs on GLP principles which are still in force today.
The above documents (Monographs) are available on the OECD website.: http://www.oecd.org/...
Further interesting information/documents, available on the OECD website:
- Frequently asked questions (FAQs): http://www.oecd.org/env/ehs/testing/glp-frequently-asked-questions.htm
- National Contact Points GLP.: http://www.oecd.org/env/ehs/testing/contact-points-working-group-on-good-laboratory-practice.htm
- Websites of the national competent authorities GLP.: http://www.oecd.org/chemicalsafety/testing/linkstonationalwebsitesongoodlaboratorypractice.htm
Community legislation on Good Laboratory Practice
The European Union has incorporated the principles of Good Laboratory Practice and the OECD compliance monitoring guidelines into the following guidelines:
- DIRECTIVE 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codification).
Directive 2004/9/EC replaced directive 88/320/ EEC from 11 March 2004.
- DIRECTIVE 2004/10 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the approximation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application in the testing of chemicals (codification).
Directive 2004/10/EC replaces directive 87/18/EEC.
Further information on GLP authorities in the European Union can be found on the corresponding webpage of the EU Directorate-General, DG GROWTH:
National legislation on Good Laboratory Practice
Community legislation on Good Laboratory Practice has been harmonized in our national legislation with the:
Decision AΧΣ 273/2000 (ΦΕΚ 1370/Β΄/9.11.2000), "Application of the principles of Good Laboratory Practice (GLP), verification of compliance with the GLP principles during studies of test items and Inspection and Accreditation System of experimental units and test sites of GLP»
With the decision ΑΧΣ 273/2000 the directives were harmonized in our national law:
Directives 2004/9/EC and 2004/10/EC are a codification of directives 88/320/EEC and 87/18/EEC respectively as amended and in force. Consequently, their harmonisation in our national law had already been covered by Decision ΑΧΣ 273/2000.
COMPETENT NATIONAL AUTHORITY - SCOPE
Competent Greek Authority for Good Laboratory Practice
Independent Authority for Public Revenue
General Directorate of the General Chemical State Laboratory
Directorate of Energy, Industrial and Chemical Products
Tsocha 16, Ampelokipi
Τel: 210 6479250, 287
e-mail: firstname.lastname@example.org, email@example.com
- Industrial Chemicals
- Food Additives
- Animal Feed Additives
- Handbook on Good Laboratory Practice, IAPR-Athens, November 2017