主题：【分享】欧洲药典CEP证书修订更新规定指南 尝试翻译

原文由 影子(hyheying) 发表:
The changes are presented in five sections:

- Notifications (N and T)

- Typical minor revisions for Certificates of suitability for chemical purity and microbiological quality or for TSE Certificates of suitability

- Major revisions (MAJ)

- Renewal

- Transfer of holdership

Editorial changes should not be submitted as separate variations but should be reported at the same time as changes concerning the respective part of the dossier. In any case, a declaration should be provided that the content of the concerned part of the dossier has not been changed by the editorial changes (except for the change itself).

以下分五节讨论各种变更情况：

通知（N和T）

化学纯度和微生物质量的CEP证书或TSE证书的典型微小变更

重大变更（MAJ）

更新

证书持有人转让

文字性变更不应作为单独的变更提交。但是当文件相关部分变更时应当同时报告。不管怎么样，应该提供申明——除了变更本身之外，文件相关部分的内容没有发生文字性变更。[此为新增内容]

原文由 影子(hyheying) 发表:

原文由 影子(hyheying) 发表:
The changes are presented in five sections:

- Notifications (N and T)

- Typical minor revisions for Certificates of suitability for chemical purity and microbiological quality or for TSE Certificates of suitability

- Major revisions (MAJ)

- Renewal

- Transfer of holdership

Editorial changes should not be submitted as separate variations but should be reported at the same time as changes concerning the respective part of the dossier. In any case, a declaration should be provided that the content of the concerned part of the dossier has not been changed by the editorial changes (except for the change itself).

以下分五节讨论各种变更情况：

通知（N和T）

化学纯度和微生物质量的CEP证书或TSE证书的典型微小变更

重大变更（MAJ）

更新

证书持有人转让

文字性变更不应作为单独的变更提交。但是当文件相关部分变更时应当同时报告。不管怎么样，应该提供申明——除了变更本身之外，文件相关部分的内容没有发生文字性变更。[此为新增内容]

In any case, a declaration should be provided that the content of the concerned part of the dossier has not been changed by the editorial changes (except for the change itself). 不管怎么样，应该提供申明——除了变更本身之外，文件相关部分的内容没有发生文字性变更。

觉得这句话似乎不妥，个人认为应该是：除了变更本身之外，文件相关部分的内容没有因文字性的变更而发生变更。也就是说以前的编辑错误不影响相关部分的实际内容。比方说，在做相关物质HPLC检测的时候，分离度通常是不低于2.0（not less than 2.0），结果在编辑的时候写成not more than 2.0了，这显然是一个编辑错误，改正之后是不影响其实际内容的，但是如果想改成not more than 1.5，对实际内容就应该是有影响的了。

不知我的理解是否正确？

原文由 影子(hyheying) 发表:
每次看到下面的这两种表示方法时总要想半天：

the currently approved (batch size, specification): 现行的已被批准的(批量，规格) ------也就是变更前已经过正式批准的批量、规格

the proposed (batch size, specification): 被提议的(批量，规格）------也就是想要变更尚未批准的新批量、新规格