Resumo

MORA HUERTAS, Claudia Elizabeth. Good Manufacturing Practices "New approaches". Rev. colomb. cienc. quim. farm. [online]. 2009, vol.38, n.1, pp.42-58. ISSN 0034-7418.

During the previous years, the Good Manufacturing Practices (GMP) , besides contributing in improving the pharmaceutical products quality, has allowed an important progress in both the understanding and the practical application in the real meaning of the quality assurance in the pharmaceutical industry. As a contribution to this issue, this document studies the contributions of the good engineering practices, the product development, the corrective and preventive action system, the quality risk management, the process analytical technology and the pharmaceutical quality system. The implementation of these concepts, that in the majority of cases are not explicit gmp guide requirements, could suppose spending more money from the firm. However, on the contrary, it would give obvious benefits and contribute to have evidence, especially for the competent national authorities, about the fulfillment quality police implementation.

Palavras-chave : GMP; quality assurance; pharmaceutical industry.

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