CGMP问答 生产和工艺控制（1）

一沙一叶

1. Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or other file?  Assuming each major piece of equipment has a unique "Cleaning and Use Log" that is adequately retained, is it acceptable to discard these 'quick reference' equipment labels?

The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment, but no similar requirement exists for retaining what are intended to be "quick reference" or temporary status labels.  Examples of these kinds of status labels include "mixing lot ###"; "clean, ready for use as of d/M/y"; "not clean."  We see no value in the retention of such labels in addition to the required equipment log or batch record documentation.  The labels serve a valuable, temporary purpose of positively identifying the current status of equipment and the material under process.  Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment.  The information on the temporary status label should correspond with the information recorded in the equipment cleaning and use log, or the previous batch record for non-dedicated equipment.

Labels are merely one way to display temporary status information about a piece of equipment.  It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards.  And it would be appropriate for an FDA investigator to verify that the information on a temporary status label is consistent with the log.

CGMP是否要求公司将设备状态识别标签与批记录或其它文件一起保管？如果每个重要设备都有自己的“清洁和使用志”并妥善保管，那么是否可以将这种“快速参考”的设备标签丢弃？

  制剂的CGMP法规要求保留非专用设备的清洁和使用日志，但没有类似的要求保留用作“快速参考”或暂时的状态标签。 这 些状态标签的例子，包括“混合批号###”；“清洁备用，日期”“非清洁”。除了要求的设备日志或者批记录文件外，我们不认为保留这些标签有何意义。这些标签是为了临时的、有价值的正确标明工艺进行时设备和物料状态。任何状态标签都应该是正确的、合法的、清晰可见的并且标在正确的设备上。临时状态标签上的信息要与非专用设备的设备清洁和使用日志上的信息或上一批批记录的信息一致。

   标签只是一种展示一个设备临时状态的方式。可以考虑将这些临时的设备状态信息标在干擦板或粉笔板上。而且FDA检察官可以确认临时状态标签上的信息与日志上内容一致。

怀谷

谢谢！

yop888

谢谢。
可以告诉该问答的出处吗

一沙一叶

yop888 发表于 2014-4-21 16:24
谢谢。
可以告诉该问答的出处吗

Fda 网站。

yop888

一沙一叶 发表于 2014-4-21 17:19
Fda 网站。

谢谢！                                    

1967537234

谢谢