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AAPS/ISPE panels feel quality summary should be ICH document.(QOS)
By Validation Times Staff
NORTH BETHESDA, MD -- While FDA's move to the new "quality overall summary" (QOS) has won praise from industry, a breakout session on the issue reported here that the document should pass ICH muster before it is used.
"If there is a decision to revisit QOS, it should globally harmonized through the ICH process," the QOS panel concluded.
QOS is already used in Japan and Canada as an important part of CMC review. FDA is emulating the Health Canada approach for its purposes.
But questions abounded about what should go into the document and how it should be used in the CMC review process, including:
1. What are the current challenges in preparing QOSs for global submissions and what challenges can be anticipated in revisiting the document to achieve a better QOS?
2. Should a harmonized QOS be an ICH topic?
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