Page 52 - 实用英语手册电子书

（9）易受…影响，易患…疾病
The manufacture of sterile products is subject to special requirements in order
to minimize risks of microbial, particulate and pyrogen contamination

（10）可获得的，可购得的，可找到的，有空的
Drawings for these utility systems should be available.
（11）涵盖…

a. The manufacture of sterile products covers a wide range of sterile product types.
b. QRM priorities should include good design of the facility, equipment and process in the first
instance.
（12）论证…
Limits are applied using cfu throughout the document. If different or new technologies are used
that present results in a manner different from cfu, the manufacturer should scientifically justify
the limits applied and where possible correlate them to cfu.

（13）及时
a. QA should be informed in a timely manner/ immediately/timely of any deviations that were
happened during production.

（14）修订/更新…
a. The SOP will be revised by the end of this month.
b. The production schedule should be updated.
（15）发放（如文件等）

SOPs should be issued to related departments by QA.
（16）递交（如文件、申请等）

This application must be submitted to CDER within this month.
（17）趋势分析
Results for critical parameters and critical quality attributes should be subject to regular trend
analysis to ensure that system capabilities remain appropriate.

（18）识别…（风险、原因）
- 44 -