关于清洁验证回收率问题

福娃晕晕

Acceptable variation for recovery results at one spiked level is typically on the order 15-30% RSD.If recovery studies are done by more than one swab operator,it is also appropriate to have a criterion for determining acceptable variation between operators.Examples of criteria used include variation of no more than a maximum amount between average percentage values,or variation of no more than a maximum relative percentage between average percentage values.Use of statistical tests for significance is generally not necessary for such determinations.

来源：PDA TR No.29 POINTS TO CONSIDER FOR CLEANING VALIDATION /6.5.2 SWAB/WIPE RECOVERY