East African Community Secretariat Arusha: 21 February 2014: A ten-day regional training program on Good Manufacturing Practice (GMP) closed today in Nairobi, Kenya. The training was organized by the EAC Secretariat under the Medicines Regulation Harmonization Program and was facilitated by experts from the region and the World Health Organization.
The programme aimed at imparting knowledge and practical skills to staff of National Medicines Regulatory Authorities (NMRAs) in the Partner States on carrying out inspections for pharmaceutical products.
In her closing remarks, the EAC Deputy Secretary General in charge of Productive and Social Sectors, Hon. Jesca Eriyo, urged participants to translate the knowledge gained into practical application. She recommended that the program should create a database of inspectors in the region and create centres of excellence in medicines regulation.
Participants were drawn from the NMRAs of Pharmacy and Poisons Board of Kenya, Tanzania Food and Drugs Authority, Zanzibar Food and Drugs Board, Department of Pharmaceuticals and Medical Laboratories of Burundi, Pharmacy Task Force of Rwanda, and National Drug Authority of Uganda.
The training modules covered the areas of risk management; hygiene and health; self-inspection; validation; water purification; heating, ventilation and air conditioning; quality control testing; and techniques for the conduct of regulatory inspections.
Participants had the opportunity to perform practical inspection of five pharmaceutical companies located in Nairobi, namely Elys Chemical Industries Limited, Universal Corporation, Regal Pharmaceuticals, Lab and Allied, and Ivee Infusion Limited.
The training would ensure uniformity of competencies among inspectors and provided an opportunity to pilot the EAC harmonized standards on GMP inspection.
It is expected that the regulators will be able to improve their oversight of the quality of medicines in the region and to contribute to the ultimate goal of increased access to priority medicines through harmonization and streamlining of medicines registration requirements, processes and standards.
Owora Richard Othieno,
Head of Department;
Corporate Communications and Public Affairs; Tel: +255 784 835021;
Corporate Communications and Public Affairs Department
EAC Secretariat Arusha, Tanzania