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Abstract:  Compounding pharmacies in Brazil have to comply with a complex and strict set of drug manufacturing regulations. The authors reported in the International Journal of Pharmaceutical Compounding (November/December 2009, Volume 13, Issue 6) on the development and implementation of a National System for the Monitoring and Improvement of Compounding Practices in Brazil, a process-focused program aiming to help compounding pharmacies improve drug manufacturing processes and meet the standards set forth by the applicable legislation. This article reports the results obtained in the first three editions of the National System for the Monitoring and Improvement of Compounding Practices in Brazil (2006 – 2010) and presents new foci explored in the 2011 cycle. The results obtained over the years demonstrate that participating in the National System for the Monitoring and Improvement of Compounding Practices in Brazil has helped pharmacies achieve legal compliance and improve the quality of their preparations, which has contributed substantially to meeting quality standards never before achieved in the compounding sector in Brazil.

Related Keywords: Brazil, drug manufacturing processes, quality standards, quality control, audit, continuing pharmacy education

Related Categories: LEGAL, QUALITY CONTROL, PHARMACY EDUCATION, PROFESSIONAL ISSUES

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