If manufacturers perform these activities as required by the QS regulation and as expounded in this manual, they should be prepared for a GMP inspectionof their operations by an FDA investigator.
The terms "vessels" and "Marine installations" as mentioned in this section mean the same as those of the corresponding terms used in the Regulation on Inspectionof vessels and Marine installations.
本节所称船舶,海上设施,其含义与《船舶和海上设施检验条例》使用的同一用语的含义相同。
3
Detailed requirements regarding the inspection and enforcement system referred to in paragraph 1 of this Regulation are set out in Part a of the Code.