shall, should, may, can 的翻译曾出现在我的帖中, 但其实来自GBT20000.2-2009标准化工作指南第2部分_采用国际标准(见http://bbs.instrument.com.cn/shtml/20100210/2396426/ )

在我使用BS, ASTM和ISO的经验中, 觉得shall代表强制性条文, 译成“必须”较合适。 (见1#, http://bbs.instrument.com.cn/shtml/20090810/2050550/ )

其实, 这类文件的条文只分强制性(mandatory)和非强制性(non-mandatory, 或称之informative clauses, recommendation, suggestion). 见到shall or must 就是强制性条文了, “必须”遵循。

This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeial requirements. This guidance does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents should be met.

本指南不是为了规定注册和/或归档要求、或修改药典要求。不影响药政负责部门在原料药上市/生产许可或药品申请方面建立特定注册/归档要求的能力。应满足注册/归档的所有承诺。

When the word “file” is used as a verb (or a gerund), it sometimes means “to submit”; therefore, “registration and/or filing requirements” may mean注册和/或递交(注册文件)要求. As the purpose of递交(注册文件) is to apply for registration, “registration and/or filing requirements” may意译为 “注册和/或申请要求” or 直译为 “注册和/或递交要求”

= = = = = =

Information :

file :

to submit documents necessary to initiate a legal proceeding (http://www.merriam-webster.com/dictionary/file)
to send something official (http://www.macmillandictionary.com/dictionary/american/file_15)
to start the process of a legal action, to register or to put something on public record. (http://www.yourdictionary.com/file)
to bring before a court or legislative body by presenting proper papers in a regular way (http://machaut.uchicago.edu/?resource=Webster%27s&word=file&use1913=ohttp://machaut.uchicago.edu/?resource=Webster%27s&word=file&use1913=on)

学习了

1.2 Regulatory Applicability 1.2法规的适用性

Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this guidance.

在世界范围内对原料药的法定分类是各不相同的。当某物料在某个地区或国家被划分为原料药用于制剂的生产或使用时，就应该按照本指南进行生产。

“当某物料在某个地区或国家被划分为原料药用于制剂的生产或使用时” 好像是指“当某物料在某个地区或国家被划分为原料药, 而此原料药用于制剂的生产或使用时” 。

但我觉得原文的意思好像是“若某物料在某个地区或国家被划分为原料药, 当生产该物料或将该物料用于制剂时”



换句话说, ( Manufacture该物料) or ( use 该物料in producing drug ) 时, according to this guidance

惭愧惭愧，我没有仔细理顺句子的结构。

1.2 Regulatory Applicability 1.2法规的适用性

Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this guidance.

在世界范围内对原料药的法定分类是各不相同的。若某物料在某个地区或国家被划分为原料药, 当生产该物料或将该物料用于制剂时，就应该按照本指南进行生产。



1.3 Scope 1.3范围

This guidance applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidances for drug (medicinal) products as defined by local authorities.

本指南适用于人用药品所用原料药的生产。它适用于无菌原料药在灭菌前的步骤。本指南不包括无菌原料药的消毒和灭菌工艺，但是，应当符合地方当局所规定的药品生产的GMP指南。

此处关于Drug (Medicinal) Product的翻译有些疑问。在本指南中术语定义中指出 Drug (Medicinal) Product意思为The dosage form in the final immediate packaging intended for marketing. (Reference Q1A)。因此把Drug (Medicinal) Product合并译为药品或者制剂。不知是否可行

专业名词留待专业人士翻译, 否则很容易闹笑话。 困扰我的是immediately prior to难译。 (曾见过immediately after被译成 “紧后于”)

法规类型的英语，就是这样子的习惯，不是普通英语的写法