Preliminary survey report on the assessment of manufacturing capacity status, good manufacturing practice and adherence to environmental, health and safety standards among selected local pharmaceutical manufacturers in 10 pilot countries

Abstract

The Executive Council of the African Union endorsed the Pharmaceutical Manufacturing Plan for Africa at its eleventh ordinary session, in Accra in 2007. The objective was to promote the local production of pharmaceutical and related non-pharmaceutical products in Africa. The Economic Commission for Africa (ECA), in collaboration with the African Union Commission, the African Union Development Agency, the World Health Organization (WHO), the Joint United Nations Programme on HIV/ AIDS (UNAIDS), the United Nations Population Fund (UNFPA) and other relevant United Nations agencies, commissioned a pharmaceutical initiative project, anchored on the African Continental Free Trade Area, in several selected African countries (Comoros, Djibouti, Eritrea, Ethiopia, Kenya, Madagascar, Mauritius, Rwanda, Seychelles and Sudan). The resulting Pharmaceutical Initiative focuses on sexual, reproductive, maternal, neonatal and child health-care products, with a view to tackling persistent challenges and unmet needs in those areas and facilitating access to reproductive health products across the region. The present assessment was carried out to determine the capacity for local production in select manufacturers within the pilot countries. To that end, surveys were undertaken: To assess the capacity of the identified pharmaceutical manufacturers and their GMP status in respect of the manufacture of the selected sexual, reproductive, maternal, neonatal and child health products in the ten pilot countries; To identify and design the capacity-building and training programmes required in the manufacturing companies in the ten pilot countries; To identify the priority environmental health and safety standards and propose standard operating procedures to promote environmental health and safety in pharmaceutical manufacturing plants in the ten pilot countries.