Conformity assessment of a high-performance liquid chromatography calibration.
1 Center of Molecular Immunology, Engineering Management, Metrology Department, 216 esq 15 Atabey Havana, Cuba
2 Center of Molecular Immunology, Quality Management, Validation Department, 216 esq 15 Atabey Havana, Cuba
This evaluation presents the results obtained in the study of the qualification protocol of the High Performance Liquid Chromatography (HPLC) in the Center of Molecular Immunology. As a criterion for the Conformity Assessment Calibration of different measurement channels, it is proposed to obtain a Probability of Calibration Conformance greater than or equal to 95% in concordance with existing regulations for the biopharmaceutical industry. This can be achieved by calculating the measurement capability, an index closely related to the evaluation of the uncertainty of the measured parameter and tolerance of process involving this measurement, which determines the range of acceptable fit for the measurement channel in accordance with the probability of the desired calibration line.
© Owned by the authors, published by EDP Sciences, 2013
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