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.
在良好的工作条件和符合适航要求下,执行工作计划和检查,以确保所有工具、技术手册和备份文件的使用是有效的。
Implement schedule and checks to ensure that all tools, technical manuals and spares used are up to date and, in good working condition and in compliance with airworthiness requirements.
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