Regulatory Focus™ > News Articles > Brazilian Regulators Issue Pharmaceutical Water Quality Guidance

Brazilian Regulators Issue Pharmaceutical Water Quality Guidance

Posted 04 February 2013 | By

Brazil's National Health Surveillance Agency (Anvisa) has issued a Guide to Quality Water Purification Systems for Pharmaceutical use which is directed to pharmaceutical manufacturers in Brazil. 

The guidance presents the minimum requirements for the materials, construction, maintenance, operation and control of the distribution of water for pharmaceutical use. The guide also represents the harmonization of regulatory requirements in health inspections conducted by the National Sanitary Surveillance (SNVS). 

Resolution RDC 17/2010 adopted for the first time a chapter exclusively for the generation and distribution systems for water for pharmaceutical use. The guidance furthers the purpose of that Resolution.

The guidance, Anvisa explained, is based on international benchmarks and national experience.


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