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Review
. 2015 Apr-Jun;7(2):87-96.
doi: 10.4103/0975-7406.154424.

Good manufacturing practices for medicinal products for human use

Bruno G Gouveia  1 , Patrícia Rijo  2 , Tânia S Gonçalo  1 , Catarina P Reis  2
Affiliations
Review

Good manufacturing practices for medicinal products for human use

Bruno G Gouveia et al. J Pharm Bioallied Sci. 2015 Apr-Jun.

Abstract

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.

Keywords: Good Manufacturing Practices; pharmaceutical industry; quality; regulatory authorities; security and effectiveness.

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Conflict of interest statement

Conflict of Interest: None declared.

References

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