For ANDA batch (prepared in manufacturing site, pilot scale, used for
stability testing and ANDA application) requires a COA. Testing is
done mainly in R&D lab with some testing in QC. Who should issue
COA? Can R&D lab issue COA for initial testing of ANDA
batch? Stability is also mainly done in R&D lab for the same
ANDA/Stability. Stability report issued by R&D lab. Trying to avoid
stricter QA on QC which delays issuing COA.
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Ranjith Gamage
Beijing Pharma
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