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TanzaniaTanzania is located in East Africa along the Indian Ocean, with Kenya to the north and Mozambique to the south. The nation was formed when Tanganyika and Zanzibar merged in 1964, after achieving independence from Great Britain. Tanzania's nearly 40 million people are at high risk for infectious diseases, particularly bacterial diarrhea and malaria. HIV/AIDS has also taken a heavy toll, putting the median age in Tanzania at less than 18 years. Young children are at especially high risk. Diarrheal diseases, for example, cause the death of an estimated three million children a year in developing countries and contribute substantially to malnutrition in surviving children. Zinc supplementation–taking oral zinc sulfate medicine in addition to the standard oral rehydration solution (ORS) regimen–was recommended in the official World Health Organization (WHO)/UNICEF treatment guidelines in 2004 after having been shown in clinical trials to reduce the duration and severity of childhood diarrhea. USP DQI teamed with WHO, UNICEF, USAID, and the Johns Hopkins Bloomberg School of Public Health to develop guidelines that will help policy makers and program managers procure quality zinc products and provide pharmaceutical manufacturers with quality standards to produce medicinal–use zinc in oral forms that children will take. Through this collaborative effort, USP DQI has provided technical assistance to selected manufacturers of zinc formulations, including one company in Tanzania. In 2006 USP DQI staff tested the manufacturer's zinc samples and, later that year, conducted a Good Manufacturing Practices (GMP) audit at its pharmaceutical plant. The audit assessed the company's level of GMP compliance compared to accepted international standards to determine their status toward achieving WHO prequalification for manufacturing zinc sulfate. USP DQI continues to provide technical assistance, training on laboratory testing techniques, and guidance and regularly monitors the manufacturer's progress. USP DQI also assists Tanzania in its fight against malaria. Approximately 90% of all malaria deaths in the world occur in Sub–Saharan Africa, and malaria causes at least 20% of all deaths in young children. USP DQI staff conducted a pre–assessment of a major pharmaceutical manufacturer that produces antimalarial drugs in 2003, and in 2006 co–organized the first "Africa Regional Consultative Workshop on Antimalarial Drug Quality" in Dar es Salaam. |
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