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Good manufacturing practices for medicinal products for human use

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for h...

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Detalles Bibliográficos
Autores principales: Gouveia, Bruno G., Rijo, Patrícia, Gonçalo, Tânia S., Reis, Catarina P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4399016/
https://www.ncbi.nlm.nih.gov/pubmed/25883511
http://dx.doi.org/10.4103/0975-7406.154424
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author Gouveia, Bruno G.
Rijo, Patrícia
Gonçalo, Tânia S.
Reis, Catarina P.
author_facet Gouveia, Bruno G.
Rijo, Patrícia
Gonçalo, Tânia S.
Reis, Catarina P.
author_sort Gouveia, Bruno G.
collection PubMed
description At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.
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spelling pubmed-43990162015-04-16 Good manufacturing practices for medicinal products for human use Gouveia, Bruno G. Rijo, Patrícia Gonçalo, Tânia S. Reis, Catarina P. J Pharm Bioallied Sci Review Article At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4399016/ /pubmed/25883511 http://dx.doi.org/10.4103/0975-7406.154424 Text en Copyright: © Journal of Pharmacy and Bioallied Sciences http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Gouveia, Bruno G.
Rijo, Patrícia
Gonçalo, Tânia S.
Reis, Catarina P.
Good manufacturing practices for medicinal products for human use
title Good manufacturing practices for medicinal products for human use
title_full Good manufacturing practices for medicinal products for human use
title_fullStr Good manufacturing practices for medicinal products for human use
title_full_unstemmed Good manufacturing practices for medicinal products for human use
title_short Good manufacturing practices for medicinal products for human use
title_sort good manufacturing practices for medicinal products for human use
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4399016/
https://www.ncbi.nlm.nih.gov/pubmed/25883511
http://dx.doi.org/10.4103/0975-7406.154424
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