制药英语课堂丨设施

您可以边看文字和视频，双重记忆保障、学习更牢固。

您也可以放松双眼，让给耳朵享受美妙、纯正的中英文听力。

[Source 来源: FDA] Guidance for Industry: Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, October 2019, FDA

The term facility means a business or other entity under one management, either direct or indirect, and at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form. The term facility does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.

术语“设施”是指在一个管理机构中 (直接或间接) ，并在一个地理位置或地址上，从事生产或加工活性药物成分或成品制剂的企业或其它实体。设施一词不包括其生产或加工活动只有以下一项或多项的企业或其它实体：重新包装、重新贴标或检测。

[Source 来源: WHO] WHO good manufacturing practices for pharmaceutical products containing hazardous substances, WHO

The built environment within which the clean area installation and associated controlled environments operate together with their supporting infrastructure.

建造环境，在其内部，洁净区域配置、相关的受控环境与其支持基础结构一起共同运行。

※ 本词条来源：《全球制药术语英汉双解词典》

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文章来源：蒲公英Camp