【周末版】ECA新闻：设备状态标识要不要保留在批生产记录里？

ECA原文：http://www.gmp-compliance.org/en ... ch%20Record%3F_8391,8382,8530,Z-QAMPP_n.html

FDA原文：http://www.fda.gov/Drugs/Guidanc ... ances/ucm124782.htm

Should Equipment Status Identification Labels be retained with the Batch Record?

设备状态标识要不要保留在批生产记录？

Keeping equipment status identification labels with the batch record or other files is often done to provide additional confirmation during review of the record. It supports verification that certain equipment was cleaned before usage for manufacturing. But is it required?

工厂通常会将设备状态标识保存在批生产记录或其它文件中，以便在审核批记录时进行确认。它表明指定的设备在用于生产前经过了清洁。但这是不是法规的要求呢？

The U.S. Food and Drug Administration (FDA) has answered this question in an Q&A Document. Assuming each major piece of equipment has a unique "Cleaning and Use Log" that is adequately retained, these "quick reference" equipment labels can be discarded according to the agency. The FDA sees "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."

美国FDA在问答文件上回答了这个问题。根据官方说法，如果每个主要设备都保存有一个唯一的“使用和清洁日志”，这些“快速索引”设备标识可以丢掉。FDA认为“除了要求设备日志或批生产记录以外，再保留这些标识没有意义。这些标识是为了有效标识设备的现在、临时的状态，以及正在加工的物料。所有状态标识均应正确、清晰、易读并与对应设备正确相关联。该临时状态标识上的信息应与设备使用和清洁日志上的信息保持一致，如果是非专用设备，则与上批生产记录信息保持一致。”

However, as said before, it might be useful to keep these labels in a batch record. Many companies are doing so; not because it is a requirement but it is a helpful and reliable practice.

但是，正如前面所说，将这些标识保存在批生产记录中可能是有用的。许多公司都在这么做，不是因为它是官方法规要求，而是因为它比较有帮助并且可靠。

Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Production and Process Controls

CGMP问答，二级指南-----生产和工艺控制

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? CGMP是否要求一个公司将设备状态标识保存在批生记录中或其它文件中？如果每个主要设备都已保留有“使用和清洁日志”，是否可以将这些“快速索引”设备标识丢弃？

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.

制剂的CGMP法规要求保留非专用设备的使用和清洁日志，但对于将用于“快速索引”或临时标识的状态标识进行保留并没有类似的要求。该类状态标识的例子包括“混合中批号###”、“清洁可用，年月日”、“未清洁”。我们认为除了要求设备日志或批生产记录以外，再保留这些标识没有意义。这些标识是为了有效标识设备的现在、临时的状态，以及正在加工的物料。所有状态标识均应正确、清晰、易读并与对应设备正确相关联。该临时状态标识上的信息应与设备使用和清洁日志上的信息保持一致，如果是非专用设备，则与上批生产记录信息保持一致。

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.

标识仅是一种展现单个设备临时状态信息的方式。在可擦写板上或黑板上展现这些临时设备信息都被认为是可以接受的。FDA检查员可以在现场对这些临时状态信息进行确认，核对其是否与日志一致。

References: 参考文献

21 CFR 211.182: Equipment cleaning and use log 设备使用和清洁日志

21 CFR 211.105:  Equipment identification 设备识别

Contact for further information: 更多信息联系人

Brian Hasselbalch, CDER

brian.hasselbalch@fda.hhs.gov

在这个论坛上能学习的 好多啊