Pharmaceutical industrial equipment qualification in Brazil: a strategic test proposal for vaccine secondary material packaging lines-Reference-Cited by-同舟云学术

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Pharmaceutical industrial equipment qualification in Brazil: a strategic test proposal for vaccine secondary material packaging lines

Published:2020-07-04 Issue:5 Volume:10 Page:1181-1194
ISSN:2190-7188
Container-title:Health and Technology
language:en
Short-container-title:Health Technol.

Author:

Menezes Thiago Jorge Teixeira^ORCID,Gomes Carlos Francisco Simões^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Link

https://link.springer.com/content/pdf/10.1007/s12553-020-00447-0.pdf

Reference30 articles.

1. Gadelha CA, Quental C, Fialho BC. Saúde e inovação: uma abordagem sistêmica das indústrias da saúde. Cad Saúde Pública, 19(1):47–59, jan./fev. 2013.

2. Geyer ARC, Sousa VD, Silveira D. Quality of medicines: deficiencies found by Brazilian health regulatory agency (ANVISA) on good manufacturing practices international inspections. PLoS One. 2018;13(8):1–17.

3. Pharmaceutical Products Industry Union in the State of São Paulo. Workshop: main deviations found in GMP inspections carried out by ANVISA - tools to deal with non-conformities. São Paulo: SINDUSFARMA; 2015.

4. Moretto LD, Calixto J. Qualificações e validações na indústria farmacêutica: v. 17. São Paulo: SINDUSFARMA; 2016.

5. Food and Drug Administration. Guidance for industry: process validation: general principles and practices. Washington: FDA; 2010.

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