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Abstract
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Recent years have seen considerable expansion in the objective of analytical determinations across a diverse range of disciplines and applications. For drug analysis, there is currently a concerted effort to complement target‐based screening for what is known to potentially be present in a sample with non‐targeted screening to detect any relevant unknown compounds.
The paradigm shift from target‐testing of a defined compound list to complementary targeted/non‐targeted screening strategies has been largely driven by customers representing regulatory agencies. To meet this demand, drug testing laboratories have developed non‐targeted (also called 'suspect') screening workflows to maintain the relevance of methods applied to the analysis of samples that may contain novel compounds. The aim is to mitigate the inevitable delay in manufacture and/or procurement of all commercially available reference materials relevant to the scope of testing at any point in time. However, the resource implications for developing non‐targeted screening methods are not insignificant for laboratories which are already engaged in high‐throughput sample analysis for regulatory purposes with continuous improvement strategies supporting quality assurance. Furthermore, the validation of non‐targeted screening methods can also present a challenge for laboratories to demonstrate fitness‐for‐purpose in support of their accreditation requirements. To this end, the convention of laboratories performing suitable validation to support a defined scope of testing needs adaptation for the scenario where are a laboratory does not know exactly what it may be looking for at that point in time...
Language: en |