RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

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.


© 2022 Regulatory Affairs Professionals Society.

Tags: brazil