20150708 ECA新闻：FDA关于数据完整性的警告信

20150708 ECA新闻：FDA关于数据完整性的警告信

GMP News
08/07/2015

FDA Warning Letter on Data Integrity

FDA关于数据完整性的警告信

For authorities the integrity of data is an essential quality attribute in the manufacture of pharmaceutical products. After some serious deviations international authorities have moved the topic into the centre of their interest. In particular the US FDA issued serious violations in Warning Letters to the companies concerned.

对于药监当局来说，数据完整性是药品生产中一个基本的质量属性。在发了一些严重的偏差后，国际药监当局已经将该问题作为其关注的重点。尤其是美国FDA，他们在给相关公司的警告信中指出了严重的违规情况。

In a current letter to the API manufacturer VUAB Pharma in the Czech Republic the inspector and the authority criticised multiple aspects with regard to "failure to prevent unauthorized access or change to data and to provide controls preventing data omissions":

在最近给捷克的API生产商VUAB的警告信中，检查员和药监局批评了关于“未能阻止未经授权的登录和对数据的修改，未能防止数据丢失”的很多问题。

• 'The firm did not retain complete raw data from testing performed to assure the quality of API. The inspector revealed the firm did not properly maintain a back-up of HPLC chromatograms that form the basis of the product release decisions. The inspector revealed as well discrepancies between the printed chromatograms and the OQ protocol for the HPLC system, which is intended to demonstrate correct operation of the system (e.g. injection sequences and values to calculate relative standard deviation'
• 公司未能保持检测过程中的完整原始数据来保证API的质量。检查员发现公司未能适当维护HPLC色谱备份文件，使其成为产品放行决策的基础。检查员还发现打印出的色谱图与HPLC系统的OQ方案不一致，该确认是为了证明系统运行的正确性（例如，进样序列和RSD计算值）
• 'The quality unit was unable to retrieve the original electronic raw data because back-up discs were unreadable. The quality unit stated that back-up discs have been unreadable since at least 2013'
• 质量部门未能恢复原始电子数据，因为备份盘读不出来。质量部门说备份盘至少2013年以来就读不出来了
• 'The inspector criticised that the firm does not have proper controls in place to prevent unauthorized manipulation of labs raw electronic data. The HPLC systems did not have access controls to prevent alteration or deletion of data. The HPLC software lacked an audit trail recording any changes to the data, including: previous entries, who made changes, and when changes were made'
• 检查员批评了公司没有设置适当的控制来防止未经授权而对化验室原始电子数据进行修改。HPLC系统没有登录权限控制来防止对数据的篡改和删除。HPLC软件缺乏审计追踪来记录所有对数据的修改，包括之前输入、谁做的修改、以及什么时间做的修改
• 'The laboratory employees shared a common log-in and password to access the system'
• 化验室员工共用一个通用的用户名和密码来登录系统
• 'The firm response stated they are qualifying a new HPLC system which allows operator-specific passwords and has audit trail and back-up functions. The firm will implement as well a new electronic back-up system. FDA stated that the response lacks sufficient detail about systems and controls. Simply activating audit trail functions and instituting password controls is inadequate.'
• 公司回复说他们对新的HPLC系统进行了确认，新的系统里不同操作员有不同的用户名和密码，有审计追踪功能和备份功能。公司还将实施一个新的电子备份系统。FDA说回复缺乏关于系统和控制的足够的细节。只是激活审计追踪功能和使用密码控制是不足够的
• 'The firm failed to review historical data to ensure the quality of the products distributed to the US market'
• 公司未能对历史数据进行审核以保证在美国市场销售的产品的质量
  

In response to this list of deficiencies the FDA now expects the affected company to provide a comprehensive corrective action plan to the following points within 15 working days:

在在本缺陷清单 的回复中，FDA希望受影响的公司针对以下问题点在15个工作日内提供一份综合的纠正措施计划：

• 'Information regarding changes in the reliability of the IT infrastructure, including improved IT systems, systems  validation, revised  procedures and retraining of employees'
• 关于IT设施的可靠性的变更的信息，包括改进后的IT系统、系统验证、修订后的程序和员工再培训
• 'Procedures regarding passwords used to access the analytical instruments. All access levels for  computerised systems should be clearly defined and documented in a written procedure'
• 关于用于登录分析仪器的程序，计算机化系统的所有登录级别均应在书面程序中进行清楚界定和记录
• 'A detailed summary of the steps  taken to train the personnel on the proper use of computerised  systems'
• 对人员恰当使用计算机化系统的培训的步骤的详细总结
  

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