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The drug companies located in Brazil have until this Thursday (7) to respond and send to the National Agency of Sanitary Surveillance (ANVISA) in the form with information about the design and installation of air handling systems intended to supply their areas productive.
The decision was published in January by the Notice of Request for Information No 1/2013. The ability of air treatment systems to ensure appropriate levels of filtration, air exchange and pressure differentials required by law is fundamental to the drugs have made quality and safety for consumption.
From the information received, ANVISA is a survey of a business, based on legal determinations, which deals with the Good Manufacturing Practice for Medicinal Products. The deadline for submission of forms is 30 days from the date of publication of the notice.
According to the qualification standards of air, companies have to invest time and providenciarem adaptation, since the system involves some insurance policies, such as production areas with unique air system, with facilities in the antechambers entry areas , monitoring the pressure difference, besides the qualification system.
Click aqui and access the tutorial with guidance on completing the form.
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