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).
In
relation to how audits should be applied to Quality Control Laboratories, Tim
Sandle has written an article.
The
reference is:
Sandle, T. (2019) Auditing and Assessing The Quality Control Laboratory, Journal of GXP Compliance, 23 (4): 1-10
For a copy, please contact Tim Sandle
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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