Abstract

GONZALEZ-FUENTES, Daymara; DELGADO-FERNANDEZ, Mercedes; FONTANET-TAMAYO, Lizette  and  VALLIN-GARCIA, Antonio. Batch release for investigational products. Ing. Ind. [online]. 2012, vol.33, n.1, pp. 31-40. ISSN 1815-5936.

This paper describes a procedure for the release of investigational products at the Center of Molecular Immunology. The Procedure incorporates the knowledge and the complexity of R&D, risk assessment, correlations and factorial analysis, evaluating clinical parameters, characteristic of quality and process controls to assure the quality of the product. The systematic application of the new procedure will diminish the release time significantly, guaranteeing the quality of the product, the compliance with national/international regulations, the design space and a greater knowledge of the processes and products in development.

Keywords : batch release; quality in product development; design space; correlations; factorial analysis.

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