Good Laboratory Practice since recent past until the present

Abstrakt

A short history is presented introducing GLP in the Czech Republic since 1998. Given are the results of intensive cooperation between the Inspection Section of the State Institute for Drug Control and the official establishment of Czech GLP Monitoring Authority. Valid legislative documents related to GLP are the Act No. 157/1998 Coll., the Decree No. 238/2001 Coll., the National GLP Compliance Programme, and methodological guidelines published in parallel in the Bulletin of the Ministry of Environment and SUKL (State Instititute for Drug Control) Bulletin. Activities consisting of preparing the new Act and Decree, conclusions of the 16th Meeting of the Working Group on GLP OECD, and conclusions of the follow-up mutual joint visit of OECD Inspectors in the Czech Republic leading to the full international recognition of the Czech GLP system are described in detail.