如果制造商按本手册所解释的QS法规的要求那样完成这些活动,他们应该说已经为FDA的检查者对其运作进行GMP检查做好了准备。
If manufacturers perform these activities as required by the QS regulation and as expounded in this manual, they should be prepared for a GMP inspection of their operations by an FDA investigator.
如果制造商按本手册所解释的QS法规的要求那样完成这些活动,他们应该说已经为FDA的检查者对其运作进行GMP检查做好了准备。
If manufacturers perform these activities as required by the QS regulation and as expounded in this manual, they should be prepared for a GMP inspection of their operations by an FDA investigator.
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