VALIDATION OF EQUIPMENT IN THE PHARMACEUTICAL INDUSTRY – A BRIEF REVIEW

Authors

  • Fernanda dos Santos Azevedo Universidade Iguaçu
  • Alex Sander Baiense Universidade Iguaçu
  • Leonardo Guimarães Andrade Universidade Iguaçu

DOI:

https://doi.org/10.51891/rease.v9i11.12525

Keywords:

Validation. Equipment qualification. Pharmaceutical Industry.

Abstract

The pharmaceutical industry has the great challenge of ensuring the compliance of all its processes throughout the entire activity of its manufacturing plant. To ensure that all these stages of the process have satisfactory results, it is necessary to validate the processes involved in the manufacturing stages.By ensuring compliance with all stages involved in this cycle, the company demonstrates to Brazilian regulatory authorities compliance with the minimum necessary requirements that ensure the quality and effectiveness of its products. Therefore, validation must be well defined and made clear to public regulatory bodies.This article seeks to demonstrate the need to carry out the validation process by pharmaceutical industries in order to fulfill the requirements of Good Manufacturing Practices (GMP). A brief introduction to the topic of validation is given with an emphasis on equipment qualification in the pharmaceutical industry.

Author Biographies

Fernanda dos Santos Azevedo, Universidade Iguaçu

Bacharel em Farmácia, Universidade Iguaçu (UNIG)  

Alex Sander Baiense, Universidade Iguaçu

Orientador do Curso em Farmácia, Universidade Iguaçu (UNIG). 

Leonardo Guimarães Andrade, Universidade Iguaçu

Coorientador do Curso em Farmácia, Universidade Iguaçu (UNIG). 

Published

2023-12-08

How to Cite

Azevedo, F. dos S., Baiense, A. S., & Andrade, L. G. (2023). VALIDATION OF EQUIPMENT IN THE PHARMACEUTICAL INDUSTRY – A BRIEF REVIEW. Revista Ibero-Americana De Humanidades, Ciências E Educação, 9(11), 2100–2108. https://doi.org/10.51891/rease.v9i11.12525