“GXP” Centre of Excellence held “GMP EU” training course, December 13-20

GMP-course-newsOn December 13-20, “GXP” Centre of Excellence in cooperation with U.S. Agency for International Development funded Competitive Armenian Private Sector (CAPS) project, conducted training courses of “Good Manufacturing practices of European Union for pharmaceutical products” (GMP EU), which attended 8 representatives from 4 companies.

The course is conducted by the director of “GXP” Centre of Excellence, production director of “Liqvor” pharmaceutical company Aram Ghazarian, pharmacist-researcher of “Armenicum” Clinical Center, lecturer of pharmacokinetics in the pharmaceutical chemistry department of State University Hasmik Abrahamyan,  quality assurance specialist of “Esculap” company Sona Khachatryan, production director of “Medical Horizon” company Asbed Cassis, production deputy director of “Liqvor” company Anush Davtyan.

The topics of the courses were “Introduction of GMP; personal goals”, “Good practices of production and quality control”, “Quality management”, “Documentation”, “Sanitation and hygiene”, “Premises (with the surrounding area)”, “Equipments”, “Water for pharmaceutical use”, “Heating, ventilation and air conditioning (HVAC) systems”, “Systems of movement and changing of clothes”, “Materials”, “Personnel”, “Sterile production”, “Validation”, “HVAC and water systems validation”, “Cleaning validation”, “Computerized systems validation”, “Validation of analytical methods”, “Qualification of systems and equipments”, “Process of validation of non sterile production”, “Complaints and recalls”, “Contract manufacturing and analysis”, “Active pharmaceutical ingredients”, “Self inspection and quality audits”, “Process of GMP inspection”, “Types of GMP inspection”, “GMP inspection; the role of the inspector”, “Preparation to GMP inspection”, “Inspection”. At the last day of the course participants visited “Medical Horizon” Pharmaceutical Company, where they saw the practical application of GMP standards.

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