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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2015
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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. |
format | Online Article Text |
id | pubmed-4399016 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
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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