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The application of the GLP principles in analytical chemistry

Published on July 18, 2013   23 min

A selection of talks on Methods

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Henry Stewart Talks. The application of the GLP principles in analytical chemistry. This presentation deals with the application of the principles of good laboratory practice, in short GLP, in analytical chemistry. My name is Sergio Caroli, and I have been one of the research directors of the Istituto Superiore di Sanità, that is to say, The National Institute of Health, at which I was 42 years. In particular, I was the delegate for Italy at the OECD working group on GLP on its very inception in 1988 until I retired in 2010.
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The adoption of fit-for-purpose quality systems is nowadays of vital importance to attach credibility to experimental information generated in the context of whatever research, development, production, and control activities. The principles of GLP make no exception to this general rule, all the more so, when analytical determinations are to be carried out in the context of a GLP compliance study, the results of which play a crucial role in the decision-making process. From this standpoint, it goes without saying that all steps of the analysis, from sampling to method validation should be carefully taken into account. In a GLP environment,
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standard operating procedures, in short SOPs, summarize routine activities common to a number of studies. In other words, SOPs are documented procedures which describe how to perform assays or activities, not normally specified in detail in study plans or test guidelines. Thus, avoiding unnecessary repetitions in the study plans. In practice, SOPs are the quality manual of a test facility. In the case of analytical measurements, SOPs should be available primarily for the correct management of instrumentation of any kind, ancillary apparatus included, throughout their entire life cycle.

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