title: Good manufacturing practices for medicinal products for human use.
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.
authors.affiliation: School of Health Sciences and Technology, Lusófona University of Humanities and Technologies, Lisbon, Portugal.
authors.forename: Bruno G
authors.initials: BG
authors.lastname: Gouveia
authors.affiliation: CBIOS-Research Center for Biosciences and Health Technologies, Lusófona University of Humanities and Technologies, Lisbon, Portugal.
authors.forename: Patrícia
authors.initials: P
authors.lastname: Rijo
authors.affiliation: School of Health Sciences and Technology, Lusófona University of Humanities and Technologies, Lisbon, Portugal.
authors.forename: Tânia S
authors.initials: TS
authors.lastname: Gonçalo
authors.affiliation: CBIOS-Research Center for Biosciences and Health Technologies, Lusófona University of Humanities and Technologies, Lisbon, Portugal.
authors.forename: Catarina P
authors.initials: CP
authors.lastname: Reis
keywords: Good Manufacturing Practices; pharmaceutical industry; quality; regulatory authorities; security and effectiveness