Supervision Administration

Analyses of Added Accreditation Requirements on the Metrological Traceability in Medicinal Testing Laboratories

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  • National Institutes for Food and Drug Control, Beijing 102629 , China

Online published: 2023-08-23

Abstract

Objective: To ensure that the metrological traceability of the measurement results obtained by the medicinal testing laboratories can effectively meet the requirements of laboratory accreditation. Methods: To interpret the key historical contexts of the new version of “Metrological Traceability Requirements for Measurement Results” issued by China National Accreditation Service for Conformity Assessment (CNAS), and highlight the significance of this revision of the document, namely, the redefinition of the International System of Units. Four authoritative organizations issued the new joint declaration on metrological traceability. The International Laboratory Accreditation Cooperation (ILAC) revised policy on metrological traceability. As a formal member of ILAC, CNAS followed up the revisions as required. On this basis, comparing the contents of the new and old revisions of the document in detail, and the revised content was interpreted from the aspects of the basis, scope, requirements, expression and structure of the new version of the document. Results and Conclusion: Based on the key revisions and changes sorted out, combined with the characteristics of the daily work for medicinal testing laboratories, it provided on operable system operation and maintenance suggestions for such laboratories to continuously meet the accreditation requirements. Meanwhile, the suggestions for reference were provided to accurately and quickly comprehend the document for other types of conformity assessment institutions and reviewers.

Cite this article

Wang Yan, Zhang Qingsheng . Analyses of Added Accreditation Requirements on the Metrological Traceability in Medicinal Testing Laboratories[J]. Chinese Pharmaceutical Affairs, 2023 , 37(8) : 897 -904 . DOI: 10.16153/j.1002-7777.2023.08.006

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