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:
http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_en
National legislation on Good Laboratory Practice
National legislation on Good Laboratory Practice
Community legislation on Good Laboratory Practice has been harmonized in our national legislation with the:
Joint Ministerial Decision of the Ministers of Finance – Development & Investments No 30/004/000/1531/15.11.2022 (Government Gazette No 5991/B/2022), "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 Test Facilities and Test Sites of GLP»
With the Joint Ministerial Decision of the Ministers of Finance – Development & Investments No 30/004/000/1531/15.11.2022 the directives 2004/9/EC and 2004/10/EC were harmonized in our national law
NATIONAL COMPETENT MONITORING AUTHORITY (CMA) - SCOPE
Hellenic Competent Monitoring Authority for Good Laboratory Practice
Independent Authority for Public Revenue
Directorate General of the General Chemical State Laboratory
Directorate of Planning & Laboratory Support
Tsocha 16, Ampelokipi
ATHENS
Τel: 210 6479241, 201, 205
e-mail: sype.gcsl@aade.gr, planning.gcsl@aade.gr
Chemicals covered by the GLP Compliance Monitoring Programme are:
- industrial chemicals
- pharmaceuticals
- veterinary medical products
- pesticides
- food additives
- feed additives
- cosmetics
- biocides
- other products (medical devices)
Types of studies covered:
1. physical-chemical tests
2. toxicity studies
3. mutagenicity studies
4. ecotoxicological studies on water & soil organisms
5. studies in the air compartment, in soil and in water; bioaccumulation
6. residues studies
7. studies of the effects on the mesocosms and the natural ecosystems
8. methods of analytical and clinical chemistry
9. others, to be specified (field studies).
Further information:
- HELLENIC G.L.P. COMPLIANCE PROGRAMME, Athens, September 2023