Quality Management

The international cooperation has been developed on the basis of collaboration and exchange of information between the member states of OECD according to the plan. The survey and assessment of the inspection activity “Annual Overview of GLP in Slovak Republic 2004” has been according to the requirements submitted to the Environment Directorate OECD, European Commission and consequently to the all member states according to the directions. This document was published at the website of Slovak National Accreditation Service www.snas.sk.

The reports on the activities and status of the Slovak Republic were presented at the 19^th Meeting of Working Group on GLP OECD in Orlando, Florida. Generally the cooperation with the member states OECD was focused on the communication, exchange of information and making comments to the drafts of directives OECD.

The international cooperation with the European Directorate for the Quality of Medicines (EDQM), European Network of Official Control Laboratories (OMCL) was focused on the development of the cooperation, effort on implementation of the unified system of quality assurance  and the exchange of information.

The international cooperation with the European Medicines Agency (EMEA)  continued in the framework of the Benchmarking by the preparation of the assessment of the quality systems implementation – audits of particular agencies. The date of the Benchmarking audit was scheduled to 17^th week 2006.

Within the international cooperation SIDC participated in the Twining Project with Turkey in the field of GLP. Two-year “Twining Project GLP Turkey” is financed and approved by EC. SIDC was accredited by EC as a “Mandated body”. In the framework of the project the materials for the working plans of training were elaborated and the professional advisory activity was performed.

SIDC Quality Manager: Dr. Ivana Šidlíková

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