FDA警告信：设备报警记录未保存，无偏差调查和CAPA

翻江鼠

有关数据完整性的检查，药监机构正在逐步增加对生产系统的关注。近日，FDA对Surmasis Pharmaceutical的警告信中提及生产设备报警记录未保存的缺陷，FDA认为应作为偏差进行调查并采取适当的措施，由于该公司未保存生产设备的报警信息，可能会对产品质量构成不可接受的风险。

缺陷摘译如下：

Your electronic data logs did not retain alarm messages indicating when certain manufacturing parameters exceed their limits during production operations. Specifically, you did not maintain electronic log records of the in-process control alarms for your (b)(4) hydrogel coating machine, your (b)(4) checkweigher, and your (b)(4) packager.

你们的电子数据日志没有保留用以指示某些生产参数在生产操作过程中何时超限的报警信息。具体而言, 你们没有保存 (b)(4) 水凝胶涂布机、(b)(4) 称重机和(b)(4) 包装机过程控制报警的电子日志记录。

Failure to record excursions of in-process limits for critical manufacturing unit operations, such as applying medicated gels to a fabric liner, rejecting over/underweight patches, and sealing packages, can pose an unacceptable risk to product quality. There is no evidence that you investigated all deviations for their effects on product quality. Specifically, any alarms that may affect manufacturing should be investigated as deviations, and appropriate action should be taken to address variability potentially introduced by the testing equipment or machine fault.

未能记录关键生产操作的过程控制超限（如将药用凝胶涂布于织物衬垫、剔除超重/重量不足半成品的和密封包装）可能会对产品质量构成不可接受的风险。没有证据表明你调查了所有偏差对产品质量的影响。具体而言, 任何可能影响生产的报警都应作为偏差进行调查，并应采取适当的措施，以解决测试设备或机器故障可能带来的变异。

In your response, you provided a list of equipment you will review for electronic data controls, but your response did not address the need to maintain a record of all deviations in the batch record in accordance with 21 CFR Part 211.188, and it lacked a global remediation to ensure electronic record retention.

在你们的答复中, 你们提供了一份将进行电子数据控制审核的设备列表, 但是你们的答复没有说明需要根据 21 CFR Part 211.188 维护批记录中所有偏差的记录, 而且缺乏全局治理以确保电子记录的保留。

In response to this letter:

回复此函，请提供：

·         Provide a complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates documentation practices and ensures that you retain complete and accurate records. This review should afford special focus to your electronic record retention and should ensure that electronic data are retained and deviations relevant to manufacturing are captured in your batch records for all manufacturing equipment with automated alarm functions.

对整个生产和实验室操作过程中使用的文件记录系统进行完整的评估, 以确定不充分的文件记录操作。包括详细的CAPA计划, 全面整改文件记录操作, 并确保保留完整和准确的记录。此审查应特别关注你们的电子记录保留, 并应确保保留电子数据, 并且，对于所有带有自动报警功能的生产设备，应在你们的批记录中记录生产相关的偏差。

·         Provide a retrospective review to determine whether potential breaches of your manufacturing parameters had any effect on the quality of products released to the market.

提供回顾性审查, 以确定潜在的违反生产参数是否对放行到市场的产品质量产生任何影响。

本文摘自GMP办公室

贾斯特耐克

大F有点严格啊

往事随风12

谢谢分享，学习一下。

lhd000000

嗯嗯

qhz1984

现在国内很多生产设备很多不带电子数据记录吧，要这样搞难度大了呀

xiaoxin220

为何是中文的。

翻江鼠

xiaoxin220 发表于 2018-11-23 15:23
为何是中文的。

翻译组翻译过来的

来自安卓APP客户端

翻江鼠

贾斯特耐克 发表于 2018-11-23 15:26
大F有点严格啊

是要更严格一些

来自安卓APP客户端

小的

学习。

一般坏而已

好严呀 ，不过现在的设备都有审计追踪了， 你干了什么记录里面都有， 这个对生产过程中，一线人员的要求无线提高呀，