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（五）常见句型 Common sentence patterns

1.QA 相关

（1）…的目的是…

a. This procedure is intended to describe the in-process control method for product A.
b. The purpose (objective) of this procedure is to describe the in-process control method for
product A.
（2）与…有关

The purpose of this SOP is to provide a technical guidance concerning /with regard to/ related
to change control.
（3）符合…规定/要求

The storage of materials should comply with/conform to/ meet the SOP requirements.
（4）…适用于…
These security requirements apply to all facilities used for medical gas distribution.

（5）维护…记录、系统、文件、设备等
Making sure that the premise and equipment are maintained and records kept.
（6）…规定…

a. The validation protocol should specify critical process steps and acceptance criteria as well as
the type of validation to be conducted.
b. It should be specified/stipulated in the SOP that …
（7） …被认为是、被看作是…

It should be noted that visual inspection alone is not considered/recognized/seen as an
acceptable integrity test method.
（8）频率的描述

Self-inspection should be conducted/performed at least once (twice, 3 times, 4 times…)
every/per year. (daily/weekly/monthly/quarterly/annually).

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