Pilot study raw data approval by QA [Regulatives / Guidelines]

posted by najatmughrabi – 2008-04-16 16:19 (6648 d 08:32 ago) – Posting: # 1778
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Dear All,

Kindly advice if QA involvement "raw data checking and approval" in a pilot BE study is needed for a study that will never be submitted to any authority. The study outcome will be used by the sponsor to determine if the formula used is ok or not prior to manufacturing the biobatch? Noting that raw data checking will be done by the laboratory manager.
Appreciating your feedback ;-)

kindest regards
Najat

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