GMP审计手册—数据管理和数据完整性（Rx-360)

beiwei5du

主要针对于GMP审计中数据管理和数据完整性方面，概念同时适用于GCP / GLP以及医疗器械。同时建议和 ISPE GAMP Records and DataIntegrity Guide.一起使用。

Rx-360 Data Integrity Working Group publishes GMP Audit Manual – Data Governance and Data Integrity

The Data Integrity Working Group is pleased to announce the release of the GMP Audit Manual – Data Governance and Data Integrity.

This data integrity audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories for data integrity and data governance elements. The scope includes the manufacture and testing of human and veterinary medicinal products regulated by FDA, intermediates, active pharmaceutical ingredients (APIs), excipients and raw materials critical to product quality.  The target audience for the audit manual is GMP auditors and stakeholders including those who have limited experience with data governance and data integrity expectations and enforcement practices.

The audit manual is to be used in conjunction with the ISPE GAMP Records and Data Integrity Guide.   The ISPE Guide  provides the framework and context for the content of the Audit Manual. The audit manual is not intended to ‘teach’ data integrity or data governance concepts.  A broad discussion of computer system classification, validation and controls may be found in the ISPE publication, GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems (2008).

麦田.守望

GMP Audit Manual Data Governance and Data Integrity和Data Integrity Checklist

2017年FDA警告信中的数据完整性缺陷分析汇总：http://rx-360.org/wp-content/upl ... ng-Letters-2017.pdf

About Rx-360:

Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The mission of the organization is timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve. To learn more about Rx-360, go to the website at www.Rx-360.org.

beiwei5du

一沙一叶 发表于 2018-4-25 09:09
RX360是什么东西啊

是制药行业供应链安全方面的联盟组织。
可参见：http://rx-360.org/about/

masterwufeng

谢谢分享

胜利者

谢谢分享

syhorchid

谢谢分享

预知子

谢谢分享

13488989948lzh

有没有中文版的啊，谢谢

岁寒三友

英文看着费劲

weiguizhang0326

牛，不错的资料。如果有中文版就更好了。

一沙一叶

RX360是什么东西啊

luislu

为什么中国就不能出点有价值且符合国情现状的指导性文件。哎。。。

Ceciliaik

谢谢分享，下载学习一下~

hongyu

谢谢分享

jingpaiqc

是英文的吗，感谢分享。

小金库

谢谢分享。

ErinTan

感谢分享！

badguy404

谢谢楼主分享！