“GXP” Center of Excellence held “Good Distribution Practice” course, October 14-15, 2010

gdp-training-newsOn October 14-15, “GXP” Center of Excellence of Medicine Producers and Importers Union of Armenia held the course dedicated to the implementation of EU “Good Distribution Practice” guidelines, which was organized in cooperation with U.S. Agency for International Development funded Competitive Armenian Private Sector (CAPS) program. The course was conducted by the assistant of pharmaceutical department of National Institute of Health named after academician S.Kh. Avdalbekyan of Ministry of Health of Armenia, PhD, “GXP” Center of Excellence certified tutor Anahit Sevikyan.

According to the Director of “GXP” Center of Excellence Aram Ghazarian, course participated representatives of pharmaceutical producing, exporting and importing 6 companies, who received full knowledge about the quality assurance systematized process of pharmaceutical production warehousing and distribution; the main elements of EU GDP guidelines; the main problems of pharmaceutical product importers; the quality assurance and the implementation of EU GDP guidelines.

Course topics included the EU legislation; EU GDP instructions; guidelines and principles; presented requirements for their implementation insuring personnel, batch documentation of their implementation, premises (with the surrounding area), equipments, as well as the processes of delivery to the customers, product return and recall, the conditions for providing of information, self inspections. It is also discussed up-to-date topics related to Good Distribution Practices sphere of pharmaceutical products. The title of one of the workshops that will take place is “How to reduce the risk during product transportation”, the other one is “Contributing factors: fluctuations of temperature during transportation”. Training participants introduced to the practical implementation of EU GDP guidelines in the pharmaceutical products importing and selling company “Tonus-Les”.

At the end of the course certificates for course graduation were given to the participants, which were approved by CAPS, “GXP” Centre of Excellence and MPI Union directors.