近日，FDA发布了对Dynamic Blending Specialists, Inc.的警告信，其中提及散装单页记录没有唯一标识符、批记录引用数据没有保存、生产和仓库区域有碎纸箱、水监测数据保存在个人电脑上等数据完整性缺陷：

Your scale calibration logs consisted of loose pages printed without unique identifiers.

你们的秤的校准日志由打印的散装页组成，没有唯一标识符。

You could not provide a non-conformance (NC) report referenced      in (b)(4) executed batch records because your previous NC data system was no longer maintained.

无法提供已执行批次记录中引用的不合格（NC）报告，因以前的不合格数据系统已不再维护。

Shred bins containing what appeared to be CGMP records were      located in your manufacturing and warehouse areas.

生产和仓库区域有碎纸箱，其中包含疑似 CGMP 记录。

Water monitoring records stored on an employee’s personal      computer could not be provided.

水监测记录存储在员工个人电脑上，无法提供查阅。

You could not provide data to support the labeled expiration      date of drug products manufactured by your facility.

无法提供数据来支持所生产的药品的有效期。

USP1029《良好文件记录规范（Good Documentation Practice, GDocP）和数据完整性（Data Integrity, DI）》中提及多页纸质记录（散装单页同理）的数据完整性控制要求：

All multiple-page data sheets or instrument printouts in paper form should be signed and/or initialed and dated on the first or last page with a note indicating the total number of pages. The first page and all subsequent pages should be uniquely identified as to the activity being performed, such as the notebook reference, study number, or worksheet reference.

所有多页纸质数据集或仪器打印输出结果，应在首页或末页签名和 / 或草签并注明日期，并标注总页数。首页及后续所有页面均应唯一标识所执行的活动，如笔记本编号、试验编号或工作记录编号。

 

来源：GMP办公室

关键词： 散装单页纸质记录 数据完整性