GMP环境中的记录副本

Copies play an important role in the GMP environment. They are used every day. And they are a data integrity issue par excellence. Where to find references to this in the regulations?

记录副本在GMP环境中起着重要的作用，每天都在使用。记录副本是一个很好的数据完整性问题。在哪里可以找到这方面的规定?

EU GMP Guide
EU GMP指南
Looking in the EU GMP Guideline, which forms of copies are distinguished, you will find two places:
在EU GMP指南中，你会发现有两种不同的记录副本形式:

4.1 ... Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems.

4.1…混合和同质系统的主文件、正式副本、数据处理和记录的关系和控制措施都需要说明。

Thus, the term "official copy" is used but not described or defined. Companies should describe or define the term "official copy" in their documentation system. It should be regulated how to deal with "official" copies and what value they have.

因此，“正式副本”被使用但并没有描述或定义。公司应在其文件系统中描述或定义“正式副本”一词。应该规范如何处理“正式”副本以及它们的价值。

In addition, duplication of working documents is also mentioned:

此外，还提到工作文件的复制:

4.2... The reproduction of working documents from master documents should not allow any error to be introduced through the reproduction process.

4.2…从主文件复制工作文件时，不应允许在复制过程中出现任何错误。

These working copies seem to be something different from official copies. Obviously, however, special attention should be paid to the copying process itself. It is up to the company to decide whether it is mandatory to distinguish between two different forms of copies.

这些工作副本似乎与正式副本不同。然而，显然应该特别注意复制过程本身。由公司决定是否必须区分两种不同形式的副本。

True Copy in GMP Regulations
GMP法规中的真实副本

A frequently used term in GMP is "true copy". EU GMP does not apply this term. The term originates from the US FDA and is first used in 21 CFR Part 211:

GMP中经常使用的术语是“真实副本”。欧盟GMP没有使用此术语。该术语起源于美国FDA，首先在21 CFR Part 211中使用:

211.180 (d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.

211.180 (d)本部分所要求的记录可作为原始记录或真实副本(如影印本、缩微胶片、缩微卡片或其他准确的原始记录复制件)保存。

In various guidelines on data integrity you will find definitions of the term "true copy" and numerous references.

在有关数据完整性的各种指南中，你会发现术语“真实副本”的定义和大量的参考资料。

WHO Guidance on Good Data and Record Management Practices

WHO良好数据与记录管理规范指南

True copy. A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including, in the case of electronic data, all essential metadata and the original record format as appropriate.

真实副本。真实副本是已被确认和证实准确、完整复制并保存原始记录整个内容和意义的原始记录数据的副本，包括使用电子数据时所有必要的元数据和原始记录格式。

MHRA GXP Data Integrity Guidance and Definitions

MHRA GXP数据完整性指南和定义

A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature) to have the same information, including data that describe the context, content, and structure, as the original.

一份原始记录的副本(不论使用何种媒介)，其经核实(即有日期的签名)具有与原始记录相同的信息，包括描述环境、内容和结构的数据。

A true copy is therefore an exact, verified copy of an original record.

因此，真实副本是原始记录的准确、经确认的副本。

The WHO verifies and certifies, but does not describe what that certification should be. The MHRA is a bit more precise on this (by providing a dated signature). The PIC/S PI 041 Draft 3 devotes a separate section to the term "true copy" under 8.10.

WHO确认和证实，但没有说明该证实应该是什么。MHRA在这方面更精确一点(通过提供有日期的签名)。PIC/S PI 041 Draft 3 8.10节给“真实副本”一词专门提供了单独的章节。

All three guidelines (WHO, MHRA and PIC/S) also describe the handling and meaning of electronic copies of the original records (scanned variant of the original paper document as pdf file).

WHO、MHRA和PIC/S的3个指南也描述了原始记录电子副本的处理和意义(原始纸质文件的扫描为pdf文件)。

       文章来源：药事佬

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