Resumo

QUINTANA ESQUIVEL, Marisel Guadalupe  e  APEZTEGUIA RODRIGUEZ, Isabel. The Good Practices in the Production of biological agents and the Quality Mangement Systems. Rev Cubana Farm [online]. 2010, vol.44, n.4, pp. 547-557. ISSN 1561-2988.

In present paper an analysis of regulators related to the Good Practices of manufacture, particularly in the biological and biotechnological methods specifying the complementary requierements fulfilled in these processes. Distinctive characteristic of biotehnological industry enphasizing its intrinsic variability due to its origin, the type of process and the use of biological trials. At XXI new paradigms of pharmaceutical industry are introduced adding the use of current management techniques type ISO 9000 and its harmonization with the Good Practices of manufacture. The curent tools are described to achieve this objetive. Authors propose to apply a system of pharmaceutical qulity according to the International Conference of Harmonization (ICH) Q10 on the base of these criteria allows to decrease the risks associated with drugs manufacture, to increase the efficiency and to achieve more success inside and ouside of the organization.

Palavras-chave : Good Practices of Manufacture; quality management system; pharmaceutical cuality system.

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