By Tim Sandle

Published in: IVT Jr GXP Compliance Vol 23 Issue 4

Published on: July 24, 2019

Abstract: The concept of quality is central to the delivery of laboratory services and this is achieved through the incorporation of quality systems, quality control and quality assurance in all aspects of laboratory practice. Essential to all aspects of laboratory results is to ensure that they are accurate, reliable and delivered in a timely fashion. To ensure that these requirements are in place and that they are consistently being met, audits should be regularly undertaken. Quality audits play an essential role in the Quality Management System and these are typically a systematic examination of a system, discrete operate, product or process. In pharmaceuticals and healthcare, the analytical laboratory function plays an important role in testing products and samples against defined acceptance criteria and this information is used for release purposes. Such laboratories tend to be organized along specific disciplines (such as chemistry or microbiology) and fall within a generalized control laboratory (or quality control laboratory) unit. Audits of the laboratory will be performed at predefined time intervals, assessing whether the laboratory complies with the defined quality system processes and this can involve procedural or results-based assessment criteria. Such audits (sometimes called ‘assessments’) can be internal (from within the company) or external (such as conducted by customers or inspectors from regulator bodies or standards / certification agencies for accreditation purposes or where inspections are performed by regulatory agencies).

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