| Category | ORIGINAL_ARTICLE |
|---|---|
| Authors | Chanda Sinha, Meena Kumari, Shagun Wadhwa, Zafar Abbas, Y Madhu, Renu Jain, G.R.Soni, Surinder Singh & Participants of the Study |
| 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 January-September 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. KEYWORDS: Assuring quality, Sodium Dodecyl Sulphate Poly Acrylamide Gel Electrophoresis, Inter-laboratory comparison, quality control. |
| Year | 2017 |
| Month | October |
| Volume | 6 |
| Issue | 4 |
| Published On | 28 Oct 2017 |
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