ASSESSMENT OF GMP COMPLIANCE IN WATER TREATMENT SYSTEMS OF PHARMACEUTICAL INDUSTRIES IN ETHIOPIA

摘要

Water is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, and assessing its quality is of paramount importance. However, to the best of the authors’ knowledge, there hasn’t been any baseline assessment made with regard to the implementation status of Good Manufacturing Practices (GMP) principles in water treatment systems of pharmaceutical industries in Ethiopia. Hence, to assess the level of compliance to GMP in water treatment systems of pharmaceutical industries in Ethiopia, a national survey was conducted in all pharmaceutical industries of the country. Data were collected by employing quantitative and qualitative methods. Self-administered questionnaires were distributed to nine pharmaceutical industries and the response rate was 8 (88.5%). According to the results, none of the industries had an influent and effluent total organic carbon monitoring system. Among the available storage tanks for purified water and water for injection, 7 (87.5%) of them were of a sanitary material. However, in 4 (50%) industries pipes were not made of sanitary material, purified water was not kept circulating at 70-80 oC and there were dead legs in the water lines. The validation results were investigated and corrective action was taken only in 1 (12.5%) of the industries. The compliance of the water treatment systems of most of the industries to WHO GMP principles was found to be below the standard in many aspects. Therefore, it is recommended that the industries should exert maximum efforts to comply with GMP principles. Keywords: Good manufacturing practices, water treatment system, pharmaceutical industry, Ethiopia, pharmaceutical water