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Validation may be established by prospective studies, KFDA says

Published: 2007-12-31 07:00:00
Updated: 2007-12-31 07:00:00
The validity of systems/equipment/tests/processes may be established and modified by prospective studies under each drug manufacturer's own circumstances, according to the Korea Food and Drug Administration.

With the imminent first-phase implementation of the current good manufacturing practice on new drugs next January, the health watchdog said that validation documents should be evaluated ...

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