Transcription of Quality Overall Summary Grounds for Revision - NIHS
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Quality Overall Summary Grounds for Revision - NIHS
Quality Overall SummaryQuality Overall SummaryGrounds for RevisionGrounds for RevisionJean-Louis ROBERT, ROBERT, Health LaboratoryNational Health LaboratoryLuxembourg (EU)Luxembourg (EU)Module not part of CTD CTDM odule 2{CTD Table of Table of from ICH CTD QOSE xtract from ICH CTD QOS (1) (1) The Quality Overall Summary (QOS) is aThe Quality Overall Summary (QOS) is asummary that follows the scope and thesummary that follows the scope and theoutline of the Body of Data in Module 3. Theoutline of the Body of Data in Module 3. TheQOS QOS should not include information, data orshould not include information, data orjustification that was not already included injustification that was not already included inModule 3 Module 3 or in other parts of the CTD. or in other parts of the from ICH CTD QOSE xtract from ICH CTD QOS (2) (2) The QOS should include sufficient information fromThe QOS should include sufficient information fromeach section to provide the Quality reviewer witheach section to provide the Quality reviewer withan overview of Module 3.}
Extract from ICH CTD – QOS (1) The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or
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