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...

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Bibliographic Details
Published in:Frontiers in public health 2022-11, Vol.10, p.1021905
Main Authors: Covarrubias, Consuelo E, Rivera, Thomas A, Soto, Catalina A, Deeks, Trevor, Kalergis, Alexis M
Format: Article
Language:English
Subjects:
antibodies
Bacillus Calmette-Guerin (BCG)
COVID-19 - prevention & control
Drug Industry
good manufacturing practices (GMP)
Humans
Pandemics
Public Health
Reference Standards
Vaccines
world health organization (WHO)
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Summary: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.
ISSN:2296-2565
2296-2565
DOI:10.3389/fpubh.2022.1021905