The first Ethiopian pharmaceutical company, SINO-ETHIOP ASSOCIATE (AFRICA) P.L.C, received official international Good Manufacturing Practices (GMP) certification as per Pharmaceutical Inspection Cooperation Scheme (PIC/S) conformity on May9th, 2009. Signifying the importance of the achievement, H.E. Juneydi Sado, Minister of Science and Technology handed over the certificate to the company. H.E. Ato Tadesse Haile, State Minister of Trade and Industry, H.E. Dr. Kebede Worku, State Minster of Health, H.E. Dr. Claas Knoop, Ambassador of Germany, H.E. Mr. Guxiaojie, Ambassador of China, Prof. Tsige G/mariam, Vice President of Addis Ababa University, Ato Yehulu Denekew, Director of Drag Administration and Control Authority (DACA) and Dr. Mebrahtu Meles, ecbp Director also attended the event.
Over the last two and a half years the Engineering Capacity Building Program (ecbp) has been working closely with the pharmaceutical industry in Ethiopia in order to make companies more competitive and increase their Good Manufacturing Practice (GMP) standards to internationally accepted levels. This assures the quality of their products as well as to give them access to larger international markets. As part of this activity a number of German senior experts in the field provided hands-on trainings and consultation to the local companies to upgrade their GMP standards and qualify them for PIC/S certification.
Pharmaceutical Inspection Cooperation Scheme (PIC/S) is a cooperative arrangement between health authorities of European Union and other countries. It is an internationally recognized organization. This PIC/S conformity certification ensures high quality, safe, and effective products are being produced at Ethiopia factories. This certification, will allow companies to export their products to the global market. The overall activities of GMP upgrading include building premises modification and renovation, installation of equipment, quality control, production improvement, documentation and utility system improvement.
Sino-Ethiop Associate (Africa) P.L.C is the first exemplary company to be certified as per PIC/S conformity. Sino-Ethiop was established in March 2001 with a strategic partnership of two Chinese Companies (China Associate Group & Dandong JINWAN Group) and an Ethiopian Company, ZAF Pharmaceuticals PLC, to develop and market Empty Hard Gelatin Capsules (EHGCs). To be certified with PIC/S Conformity Sino-Ethiop invested a great deal of time and resources with the expectation that this certification will help expand the export opportunity of the company. Currently Sino–Ethiop exports its products to African and Middle Eastern countries in addition to selling in the local market.
Background
ecbp is an Ethiopian program established under the Ministry of Capacity Building with the support of the German government. The program is designed to foster the on-going economic development of Ethiopia by improving the competitiveness of local industries in collaboration with the Ministry of Trade and Industry (MOTI), the private sector and other relevant institutions. ecbp is formulating and implementing demand-driven interventions which upgrade the capacity of the selected sectors and support institutions.
Good manufacturing practice (GMP)
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP helps to boost pharmaceutical export opportunities, since most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP.