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The swab sample shall be gathered adjacent into the defined sampling area exactly where the sample is by now collected.  These boundaries are calculated based on Safe and sound threshold values, which are determined by toxicological evaluation.If the swabbing location is modified, acceptance conditions also have to be corrected and recalculated wi

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Lastly, if 3rd parties are actually involved with the development and qualification of analytical methods, a properly-made technical transfer and proper documentation are required for maintaining the qualification standing once the transfer from the method and to enable the validation readiness assessment work out before ICH validation usually take

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