Cargando…
Current GMP standards for the production of vaccines and antibodies: An overview
The manufacture of pharmaceutical products made under good manufacturing practices (GMP) must comply with the guidelines of national regulatory bodies based on international or regional compendia. The existence of this type of regulation allows pharmaceutical laboratories to count on the standardiza...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9891391/ https://www.ncbi.nlm.nih.gov/pubmed/36743162 http://dx.doi.org/10.3389/fpubh.2022.1021905 |
_version_ | 1784881127875411968 |
---|---|
author | Covarrubias, Consuelo E. Rivera, Thomas A. Soto, Catalina A. Deeks, Trevor Kalergis, Alexis M. |
author_facet | Covarrubias, Consuelo E. Rivera, Thomas A. Soto, Catalina A. Deeks, Trevor Kalergis, Alexis M. |
author_sort | Covarrubias, Consuelo E. |
collection | PubMed |
description | The manufacture of pharmaceutical products made under good manufacturing practices (GMP) must comply with the guidelines of national regulatory bodies based on international or regional compendia. The existence of this type of regulation allows pharmaceutical laboratories to count on the standardization of high-quality production processes, obtaining a safe product for human use, with a positive impact on public health. In addition, the COVID-19 pandemic highlights the importance of having more and better-distributed manufacturing plants, emphasizing regions such as Latin America. This review shows the most important GMP standards in the world and, in particular, their relevance in the production of vaccines and antibodies. |
format | Online Article Text |
id | pubmed-9891391 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-98913912023-02-02 Current GMP standards for the production of vaccines and antibodies: An overview Covarrubias, Consuelo E. Rivera, Thomas A. Soto, Catalina A. Deeks, Trevor Kalergis, Alexis M. Front Public Health Public Health The manufacture of pharmaceutical products made under good manufacturing practices (GMP) must comply with the guidelines of national regulatory bodies based on international or regional compendia. The existence of this type of regulation allows pharmaceutical laboratories to count on the standardization of high-quality production processes, obtaining a safe product for human use, with a positive impact on public health. In addition, the COVID-19 pandemic highlights the importance of having more and better-distributed manufacturing plants, emphasizing regions such as Latin America. This review shows the most important GMP standards in the world and, in particular, their relevance in the production of vaccines and antibodies. Frontiers Media S.A. 2022-11-03 /pmc/articles/PMC9891391/ /pubmed/36743162 http://dx.doi.org/10.3389/fpubh.2022.1021905 Text en Copyright © 2022 Covarrubias, Rivera, Soto, Deeks and Kalergis. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Public Health Covarrubias, Consuelo E. Rivera, Thomas A. Soto, Catalina A. Deeks, Trevor Kalergis, Alexis M. Current GMP standards for the production of vaccines and antibodies: An overview |
title | Current GMP standards for the production of vaccines and antibodies: An overview |
title_full | Current GMP standards for the production of vaccines and antibodies: An overview |
title_fullStr | Current GMP standards for the production of vaccines and antibodies: An overview |
title_full_unstemmed | Current GMP standards for the production of vaccines and antibodies: An overview |
title_short | Current GMP standards for the production of vaccines and antibodies: An overview |
title_sort | current gmp standards for the production of vaccines and antibodies: an overview |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9891391/ https://www.ncbi.nlm.nih.gov/pubmed/36743162 http://dx.doi.org/10.3389/fpubh.2022.1021905 |
work_keys_str_mv | AT covarrubiasconsueloe currentgmpstandardsfortheproductionofvaccinesandantibodiesanoverview AT riverathomasa currentgmpstandardsfortheproductionofvaccinesandantibodiesanoverview AT sotocatalinaa currentgmpstandardsfortheproductionofvaccinesandantibodiesanoverview AT deekstrevor currentgmpstandardsfortheproductionofvaccinesandantibodiesanoverview AT kalergisalexism currentgmpstandardsfortheproductionofvaccinesandantibodiesanoverview |