GLP COMPLIANCE MONITORING PROGRAM IN ESTONIA Maia Valm

GLP COMPLIANCE MONITORING PROGRAM IN ESTONIA Maia Valm Estonian Accreditation Centre Brussels, 12. 03. 2015 1

GLP Legislation in Estonia EU Directives 2004/9/EC and 2004/10/EC adapted into Estonian legislation � Chemicals Act; � Regulation of the Minister of Social Affairs from 28 th of December 2004 No. 150 „Requirements and Procedures of Good Laboratory Practice“; � Regulation of the Minister of Social Affairs from 14 th of February 2005 No. 15 „Requirements and Procedures of Assessment and Verification to Compliance with Good Laboratory Practice“. Brussels, 12. 03. 2015 2

The National Monitoring Authority for GLP Estonian Ministry of Social Affairs has contracted the Estonian Accreditation Centre to act as the national monitoring authority for GLP in December 2005. Contract has been renewed in 2010 and will be updated again in the second half of this year. Brussels, 12. 03. 2015 3

GLP Inspection Program in Estonia � Preliminary visit took place in March 2006 � In February 2014 the first laboratory was inspected in cooperation with Swedish Board for Accreditation and Conformity Assessment (SWEDAC). � In December 2014 the follow-up visit was performed due to the moving of the laboratory to new premises. � Facilities in the monitoring program are normally inspected every two years. Brussels, 12. 03. 2015 4

Main Activities for the Implementation of the GLP Principles � Maintaining of National GLP Compliance Monitoring Programme � Starting and developing of the internal procedures for GLP inspections and study audit � Training of GLP inspectors and experts Brussels, 12. 03. 2015 5

GLP Training Activities � Training of EAK 2 staff members in SWEDAC 2006 � OECD training course in Edinburgh 2006 � Participation in GLP inspection as observer in Finland 2008 � OECD training course in Jerusalem 2011 � Participation in seminar in Helsinki 2014 Brussels, 12. 03. 2015 6

International GLP Activities � Participation at EU GLP Working Group meetings � Participation at EU GLP Working Group technical meetings � Participation at OECD GLP Working Group Meetings Brussels, 12. 03. 2015 7

Perspective � Updating the internal procedures for GLP inspections and study audit; � Preparation for the first OECD on-site evaluation of the Estonian GLP monitoring programme (presumably in February 2016) Brussels, 12. 03. 2015 8

Thank you for your attention! Brussels, 12. 03. 2015 9