VALIDATION

RDC 17/2010 (ANVISA)

Definição: Validação é um ato documentado que atesta que qualquer procedimento, processo, equipamento, material, atividade ou sistema realmente e consistentemente leva aos resultados esperados.

Current Good Manufacturing Practices (FDA/2011)

Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Process Validation

Sterilization

Equipment Validation
Process

In accordance with the various rules in force

  • ETO Autoclave

  • Steam Sterilizer

  • Dry Heat

  • Sterilization tunnel

  • De-pyrogenization

  • others

Validação de Processos Produtivos

  • Envase

  • Emblistamento

  • Selagem

  • outros

Computerized System
Validation
Transport Validation

With a primary focus on "embedded" systems, the knowledge of the production process, coupled with the thousands of qualifications of equipment performed, we have entered a few hundred hours of study and ready: an innovative VSC system - practical, simple and effective. .

One of the services that really sets us apart from the general market, the extensive research and development of an extremely high quality "product" was started in 2006, that's right, our first shipping validation was in 2006! In 2008 we began to spread this knowledge with numerous trainings on the subject, including for VISA - MG.

HORÁRIOS DE

FUNCIONAMENTO

 

SEGUNDA - SEXTA

08:00 - 20:00

​SÁBADO

​09:00 - 12:00

 

ENDEREÇO

Av. Heráclito Mourão de Miranda, 1465

Bairro: Serrano

Belo Horizonte - MG

CEP 30882-640

Tel.: (31) 3476-7492 / 3763

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MAPA

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