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Regulatory Focus™ > News Articles > Brazil Releases Guidance on Drug Manufacturing Decontamination Validation

Brazil Releases Guidance on Drug Manufacturing Decontamination Validation

Posted 08 April 2013 | By Louise Zornoza

Brazil's National Health Surveillance Agency, Anvisa, has released a pharmaceutical production cleaning validation guide which, according to the agency, is based on international guidelines.

The document is directed at pharmaceutical manufacturers in Brazil and is intended to be a simple, practical and structured approach for executing the cleaning validation necessary to demonstrate that a company's manufacturing procedures are effective in removing contaminants or lowering them to acceptable levels.

The production of pharmaceuticals involves complex chemical processes that can lead to the production of a myriad of byproducts, including toxins. The cleaning validation process is one of the most effective ways to control contamination in the active pharmaceutical ingredients.

The validation is a regulatory requirement in Brazil stemming from resolutions RDC No. 17/2010 and RDC nº 249/2005.

 

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