Collaborative study to evaluate the inter laboratory reproducibility for Gel Electrophoresis by SDS PAGE on human Erythropoietin drug samples
Journal Title: International Journal of Medical and Health Sciences - Year 2017, Vol 6, Issue 4
Abstract
Introduction: A collaborative study was carried out to determine the inter laboratory variability in purity test method on erythropoietin samples by Gel electrophoresis employing standard SDS PAGE in addition to as a pre-requisite for assuring the quality of test results reported by the laboratories. Eight different laboratories across the country participated in this study, which play an important role in Public Health Sector for availability of standard quality drugs and biologicals. All receiving identical material of Reference standard and the coded samples from the same batch. Material and method: A standard protocol was prepared complying with the requirements of Erythropoietin injection which is a published monograph in Indian Pharmacopoeia– (IP) 2014. Three independent experiments were carried out within a month of receipt of the samples. In this report we present the results of an Inter-Laboratory Comparison (ILC) study coordinated by Quality Management Unit (QMU) of NIB during JanuarySeptember 2014 for assuring the quality of results of Identification of Recombinant Human Erythropoietin (rh-EPO injection) by Gel electrophoresis as a step forward for the continuous improvement towards accreditation and compliance to the standard ISO17025:2005. Result: All the eight laboratories provided satisfactory results and these results are further evaluated, ranked under Good (50%), Excellent (37.5%) and Fair (12.5%) none of the laboratories obtained “poor” rank. Conclusion: Participations in such studies reveal indicators for the assessment of quality risk management, could contribute to the refinement of the assay for reliable identification and purity test parameter assessment.
Authors and Affiliations
Chanda Sinha, Meena Kumari, Shagun Wadhwa, Zafar Abbas, Y Madhu, Renu Jain, G. R. Soni, Surinder Singh & Participants of the Study
Keywords
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