Page 54 - 实用英语手册电子书

2.车间相关

（1）进行…（操作、测试、工作）
Repackaging should be conducted/performed under appropriate
environmental conditions to avoid contamination and cross-contamination.
（2）执行，实施…

Use of knowledge management and quality risk management will enable a company
to implement ICH Q10 effectively and successfully.
（3）最小化、最大化、最优化
a．Facilities should also be designed to minimize potential contamination
b. This change should be implemented to maximize the efficiency of QC test.
c．The purpose of this trail is to optimize the process performance.
（4）按照…

a. Records should be kept according to the procedure.
b. Appropriate risk assessment and mitigation measures should be applied and recorded as per
the manufacturers CCS（contamination control strategy）.

（5）暴露在…
Product should not be exposed to the environment.
（6）直接接触产品的…
Equipment that directly in contact with product/ come into direct contact with product
should be cleaned using a validated cleaning method.
（7）配备、装备了…

This room is equipped with reactor, centrifuge and all production necessary equipment.
（8）（物料）从…转移至…
Solid materials are transferred from normal area to clean area through pass box.

（9）阶段性生产
Production by campaign is one of the precautions that have been taken to reduce the risk of
cross-contamination.

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