On 25-26 November 2009 and 26 January 2010 Pharmaceutical Research Institute was audited by the Inspectors from the Bureau for Chemical Substances and Preparations (Lodz, Poland). The aim of the inspection was to verify the compliance of pharmacokinetic studies, e.g. bioavaialility and bioequivalence studies, performed in the Pharmacology Department.

The arrangements for the initial audit by the Inspectors from the Bureau's Good Laboratory Practice (GLP) Department were made in close cooperation with the Quality Assurance Unit. According to the Inspectors' suggestions from pre-initial audit, significant changes in the study management and documentation were implemented.

The knowledge gained during the inspection led to the conclusion that pharmacokinetic studies are performed according to the OECD principles of GLP laid down in the Directive 2004/9/EC. The quality of studies was confirmed by the Certificate of GLP Compliance No. 2/2010/GLP, which is valid through 12 January 2012.

The fact of having obtained this new certificate clearly proves that pharmacokinetic services of the Pharmaceutical Research Institute are of the highest quality. The Pharmacolgy Department has been a GLP certified unit since 2003. Previous certificates were issued by the Slovak National Accreditation Service (SNAS).

0.2 MB Certyfikat GLP nr 2/2010/GLP

0.3 MB Statement of GLP Compliance No. G 019