Glycosylation is a critical process in the production of many therapeutic proteins.

糖基化是许多治疗性蛋白质生产中的关键过程。

With SMES systems it is possible to protect critical process loads.

采用smes系统就在可能保护紧要的生产负荷.

It is intended that critical process alarms will be subjected to a similar level of oversight and controls as is currently afforded to interlocks .

意图是使关键性的工艺报警能处于与当前施加在联锁（功能）上同级的监督和控制之下。

Deviations in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.

应当调查与关键工艺步骤有关的收率偏差，以确定其对相关批号最终质量的影响或潜在影响。

Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed.

在一批原料药放行或分发之前，关键工序的批生产记录和实验室控制记录应当由质量部门审核和批准。