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RDC 301/2019 (ANVISA)

Definition: Validation is a documented act that certifies that any procedure, process, equipment, material, activity or system actually and consistently leads to the expected results.

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


Equipment Validation

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
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.

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