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Method validation in analytical sciences: discussions on current practice and future challenges

机译：分析科学中的方法验证：关于当前实践与未来挑战的讨论

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Eurachem held a workshop on method validation in analytical sciences in Gent, Belgium, on 9-10 May 2016. A summary of the working group discussions is provided here. The discussions covered a range of issues concerned with current practice and future challenges in method validation, i.e. setting requirements for a method to be validated; planning validation studies; validation of qualitative and semi-quantitative methods; validation of multi-parameter methods; determination of trueness/bias; assessment of working range; validation in microbiology; and method validation under flexible scope of accreditation. Delegates (129) from 24 different countries and from different backgrounds, e.g. from both public and private laboratories, laboratory associations, accreditation bodies and universities, attended the working groups, thus providing opportunities to collect a variety of views and experiences as well as to identify potential gaps in current guidance and regulations. While the practicalities of assessing method performance characteristics are generally well understood, the issue of setting requirements for those characteristics beforehand is less straightforward. Although a number of documents addressing the principles of method validation are available, guidance on dealing with more complex and 'non-ideal' situations, as well as examples of good practice, would be welcomed and greater harmonisation of approaches was deemed necessary. There remains a need for guidance on both the concepts that apply to 'qualitative' or 'nominal' test methods and on the practical implementation of validation studies in such cases.
机译：20016年5月9日至10日，Eurachem举办了关于Gent，比利时分析科学的方法验证研讨会。这里提供了工作组讨论的摘要。讨论涵盖了一系列关于方法验证的当前实践和未来挑战的一系列问题，即确定要验证的方法的要求;规划验证研究;验证定性和半定量方法;验证多参数方法;确定真实/偏倚;评估工作范围;微生物学中的验证;灵活的认证范围下的方法验证。代表（129）来自24个不同的国家，以及不同背景，例如，从公共和私人实验室，实验室协会，认证机构和大学都参加了工作组，从而提供了收集各种观点和经验的机会，并确定目前的指导和法规中的潜在差距。虽然评估方法性能特征的实用性通常很好地理解，但事先对这些特性的规定要求的问题不太直接。虽然提供了一些关于方法验证原则的文件，但有关处理更复杂和“非理想”情况的指导，以及良好做法的例子将受到欢迎，并更加统一互动方法。仍然需要对适用于“定性”或“名义”测试方法的概念以及在这种情况下进行验证研究的实际实施的概念的指导。

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