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vol.32 issue3THE DEVELOPMENT OF A PRODUCTION DUE TO THE GOOD MANUFACTURING PRACTICESADJUSTMENT OF PARAMETERS FOR THE STUDY OF VIRAL CHALLENGE IN THE VALIDATION OF SURFACEN® PRODUCTION PROCESS author indexsubject indexarticles search
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Revista de Salud Animal

Print version ISSN 0253-570X

Abstract

BETANCOURT, A et al. INTERNAL QUALITY CONTROL APPLIED TO CENMAST, A PRODUCT TO DETECT MASTITIS. Rev Salud Anim. [online]. 2010, vol.32, n.3, pp. 163-168. ISSN 0253-570X.

CENMAST is a diagnostic test similar to the California Mastitis Test (CMT). During the production process at Centro Nacional de Sanidad Agropecuaria (CENSA), the Quality control Laboratory tests the specifications of the product, determining the active substance, pH and density, the results are under Internal Quality Control Program. A batch was evaluated as a working reference material, to be used as a sample of quality control, also it was used for the validation of the assay precision under repeatability conditions and intermediate conditions changing the analysts, working days, equipments and calibration. A suitable precision among replicas was obtained and critical ranges of 0,03, 0,30, 0,006 were reported for the active substance, pH and density respectively. The distribution of the control sample values plotted on the control graphics demonstrated that the analytical methods are under statistic control. The quality internal control demonstrated the reliability of the results in control and product samples when evaluated in parallel.

Keywords : internal quality control; mastitis; diagnosis.

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