FDA issues Draft Guidance on Translating GLP reports into English as a Q&A styled document:
"Translation of Good Laboratory Practice Study Reports: Questions and Answers"
Link to draft guidance
The content is pretty straight forward and is intended to ensure that the content of the translated report is complete including tables and figures. The draft guidance recommends an SOP to cover the process, after the initial translation a peer review by a second translator, a signed statement on the translation but not the translated report(i.e., no requirement to have the translated report signed). A few other things are in the document to consider.
#FDA #GLP #ReportTranslation
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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