alexa Abstract | An Inter Laboratory Comparison Study on Biological Products for Bacterial Endotoxin Test


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Abstract

In a regulatory set up for biological products the symbiotic relationship for assuring the quality of test results is required to be addressed for a step wise laboratory improvement towards accreditation or inspection of facility compliance with current Good Manufacturing Practices. Pharmaceutical laboratories play a pivotal role in clinical or public health domain by providing accurate and reliable results for the quality attributes of the drug under consideration. Various strategies are adopted by testing laboratories to assure that the test results are accurate, precise, and reproducible. National Institute of Biologicals (NIB) functions as Central Drug Laboratory in India and responsibly assures and reviews the quality of number of biological products available through domestic manufacturers and imports. In this report we present the results of an inter-laboratory comparison (ILC) study coordinated by the Quality Management Unit of NIB during January-September 2014 for assuring the quality of results of bacterial endotoxin test (BET) by gel clot method. Eight laboratories participated in the ILC study and six laboratories provided satisfactory results while results from two laboratories were unsatisfactory in terms of errors in calculation of maximum valid dilution and expression of final results indicating the need for improvement in the technical competence of testing laboratories for assuring the quality of safety test parameter by BET.

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Author(s): Y. Madhu, Gaurav Pratap Singh Jadaun, N. Nanda Gopal1, Zafar Abbas, Saurav Sharma, Renu Jain1, G. R. Soni, Surinder Singh

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