Quality Control and Compliance in a Regulated Bioanalytical Laboratory-An Incessant Journey

Abstract

Basic Science and Regulatory considerations, with ‘quality’ as the focal point are two vital components of Regulated bioanalysis (RegBio). With the advancement in scientific practices through continuous learning, RegBio has progressed significantly in the past two decades. At the same time, technological advancements and new regulatory requirements have propelled local and international regulatory agencies to bring about constructive improvements to their regulatory guidance and other relevant documents. Thus, the dynamism of RegBio demands not only sound scientific knowledge but also correct understanding of regulatory aspects. The conceptualization, creation and implementation of an appropriate ‘Quality Management System (QMS)’ for a bioanalytical lab necessitate focussed and sustained efforts from the doers (analysts, laboratory professionals), quality control (QC)/quality assurance (QA) personnel as well as the management (leadership). With inference to decades of globalized practices and hands on experience, it is clearly understood that ‘Quality’ is a culture-driven phenomena, and needs to be inculcated in professionals and incorporated in the working culture of an organization at the very onset. This article focuses on the role of major stake holders of ‘Quality Management System’ for quality control and compliance in regulated bioanalysis, especially from India’s perspective.