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Skrýt nabídku

Good Laboratory Practice

Czech National GLP Monitoring Authority

  • Head: Ing. Petr Finger
  • Phone: +420 220 197 318
  • E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Good laboratory practice is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planed, performed, monitored, recorded, archived and reported.

Good laboratory practice is appointed by § 9 art. 10 Act No. 356/2003 Coll. and Decree No. 219/2004 Coll. Translation of the “OECD Council Decision [C(97)186 (final)]“ (i.e. “OECD Principles of Good Laboratory Practice”) creates Annex No. 1 to this Decree and Annex to Directive 2004/9/ES.

Obligation to establish principles of GLP is determined by Act No. 356/2003 Coll. in the wording of later regulations.

GLP is not designed for test facilities – laboratories – conducting routine supervisory analyses, e.g. process tests or analyses of drinking and waste waters, or air etc.

A new test facility included in to National Programme:
I2L Research Ltd. organizační složka
Na Zlaté stoce 1619
370 05 České Budějovice
insecticide, biocide and repellent product efficacy testing

National GLP Compliance Programme (79,6 KB, Adobe Acrobat document)
The document was prepared jointly by the representatives of national GLP monitoring authorities for the sphere of pharmaceuticals (State Institute for Drug Control SUKL, inspection section), and for the sphere of chemical substances and chemical products (T. G. Masaryk Water Research Institute, public research institution). Identical texts of the document have been published in the Bulletin of SUKL and in the Bulletin of the Ministry of Environment and on websites of both institutions. This document is determining and describing all aspects of the system established in Czech Republic.

Methodological guideline (46,5 KB, Adobe Acrobat document)
Methodological guideline of the Ministry of Environment “Methodological guideline on the execution of Act No. 356/2003 Coll. and Decree No. 219/2004 Coll., on the procedure of obtaining a Certificate of Good Laboratory Practice compliance and inclusion of the test facility in the National GLP Compliance Programme” is published in the Bulletin of the Ministry of Environment.
This guideline is founded on the legislation and the National Programme, and determines procedures actions necessary for awarding the GLP Certificate both of test facility and monitoring authority.
List of test facilities (0,18 MB, Adobe Acrobat document)

Questionnaire for test facilities (0,41 MB, MS Word document)

Useful links

Ministry of Environment
State Institute for Drug Control

OECD

GLP guidelines
Test methods