重温ICH Q7A，勉励自己坚持专业英语学习

1. INTRODUCTION

1.1 Objective

This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

1. 简介

1.1目的

本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）的有关优良药品生产管理规范（GMP）提供指南。它也意图帮助确保原料药符合其旨在达到或表明拥有的质量与纯度要求。

译文是网上流传的一个翻译版稍加修改的。最后一句话的蓝色部分有点怪怪的，不知怎样翻译合适。

我在这句话中学到了一个词purport

vt.声称；意图；意味着；打算

n.意义，要旨；目的，意图

In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent.

本指南中术语“制造”的定义包括物料接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和分发及其相关控制的所有操作。本指南中，“应当”术语表示会保证符合CGMPs希望采用的建议。可以使用替代的方法如果该法符合其适用的法规的要求。本指南中术语“现行优良生产管理规范（cGMP）”和“优良生产管理规范（GMP）”的目的是等同的。

statute [ˈstætju:t] n. 法令，法规； 规则，条例

statue 与它拼写容易混淆[ˈstætju:] n. 雕像，塑像

vt. 用雕像装饰
status [ˈsteitəs] n. 地位，身份； 状况，情形，状态； 重要地位，要人身份； 现状

In this guidance, the term should identifies recommendations [that, when followed, will ensure compliance with CGMPs.]

本指南中，术语“should” identifies 建议, 若采用该等建议会ensure符合CGMPs

= = = = = =

(意译)

本指南中，术语“应当”实为建议, 若采用该等建议会达至符合CGMPs

My above translation may not be a better one, just a suggested alternative for reference.

再看3#, 还是怪怪的不像人话, 再试另一意译:

本指南中，凡用“应当”这一术语指(or引伸)出的, 均为建议, 采用该等建议会符合CGMPs的要求。

非常感谢，受教了，之前我一直没弄明白这句话的意思

The guidance as a whole does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.

本指南在总体上未包括生产人员的安全方面，亦不包括环保方面的内容。这方面的管理是生产者固有的责任，也是国家法律规定的。

In the documents such as Guidance, Code of Practice, Standard (GB, ASTM, ISO etc.), there is a significant difference between “shall” and “should”. “shall” implies a mandatory (强制性) requirement, while “should” implies a recommendation only. It is the reader’s decision on whether to follow the recommendation based on his judgment, but following the recommendation will generally comply with certain requirements.

I believe that the purpose of clause 1.1, which is common, is to emphasize the meaning of “should”. Similarly, the clause in 7# is also a very common one in many foreign standards. The purpose of such clause is not only to remind the readers, but also作为文件撰写者的免责条欵。 (目的是: 假如完全依照有关条文去做却出了安全事故, 也不能控告撰写者疏忽)

参考了你以前发的一篇帖子

shall 译为 “应”；

shall not 译为 “不应”

should译为 “宜”

should not译为 “不宜”