Every fifth FDA Warning Letter includes deficiencies regarding Equipment

清歌一曲月如霜

所考虑的期限自2012年至2014年第一季度涉及到两家公司在美国的内外。没有一个提到的19封警告信，完全是由于设备方面的不足。然而，大图为缺乏相对于使用的生产设备FDA要求的理解。在几乎所有情况下也有提及侵犯在21 CFR规定的要求211.67（设备的清洗和维护），如缺乏系统维护或维护系统，不符合要求。在一个案例中划痕和生锈生产锅炉被发现。在另一种情况下，当局发现明显的缺陷有关的设备的状况，并且除了反对完全没有计划生产建设的维护和保养/清洁。常规校准被认为是不足的另一起案件中，和校准工作记录进行人甚至完全缺失。
生产设备的资质可以的缺点名单上找到为好。在一个案例中，例如平板电脑测试站（硬度，重量）的缺失检查的准确性依赖于不同的可能速度设置为PQ的一部分被批评。此外，片相对于压片机“不同的速度弹射被充分考虑了PQ。在发给公司在中国大陆和台湾两封警告信，对生产设备的资格被认为是完全不存在。
在大多数情况下，虽然，警告信是针对在先前的检查后发现措施不充分全面的目录。例如，在一个情况下，所要求的校正被发现会丢失。但该公司的答复缺乏有关已被制造为non-校准的设备在市场上的批次的评价信息。在另一起案件 - 受影响的是一个灌装生产线的维护和清洁 - 的评价是应该被扩展到了生产与故障系统等产品。它还预计，新创建的保养和清洗的计划，加上相对的声明，其有效性是提交。有些深奥的是另一家公司已经注意到关于丢失或缺乏维护他们的设施和清洁于2001年，2003年和2011年的情况下，在一个新的FDA检测，2012年相应的SOP处于草案状态仍然发现。


The considered period from 2012 until the first quarter of 2014 pertains to both companies in and outside of the United States. None of the 19 mentioned warning letters is solely due to deficiencies regarding equipment. However, the big picture shows the lack of understanding of FDA requirements relative to used production equipment. In almost every case there are references to violations against requirements defined in 21 CFR 211.67 (equipment cleaning and maintenance), such as the absence of a maintenance system or a maintenance system that doesn't fulfill the requirements. In one case scratches and rust in production boilers were found. In another case the authority found obvious defects with regard to the condition of the equipment, and in addition objected to the complete lack of plans for maintenance and maintenance/cleaning of the production building. The routine calibration was found to be insufficient in another case, and records of calibration work carried out were even missing completely.
The qualification of production equipment can be found on the list of shortcomings as well. In one case, for example, the missing accuracy check of a tablet test station (hardness, weight) depending on the different possible speed settings as part of the PQ was criticized. Also, the ejection of tablets in relation to the tablet press' different velocities was insufficiently considered in the PQ. In two warning letters issued to companies in China and Taiwan, the qualification of the production equipment was found to be completely absent.
In most cases, though, the warning letters are the response to an insufficiently comprehensive catalogue of measures following the findings in previous inspections. For example, in a case the required calibrations were found to be missing. But the company's reply lacked information regarding the evaluation of the batches on the market that had been manufactured withnon-calibrated equipment. In another case - affected was the maintenance and cleaning of a filling line - the evaluation was supposed to be extended to other products which had been manufactured with the faulted system. It is also expected that the newly created maintenance and cleaning plans plus a statement relative to their effectiveness is submitted as well. Somewhat abstruse is the case of another company which had already been noted with regard to the missing or deficient maintenance and cleaning of their facilities in 2001, 2003 and in 2011. In a new FDA inspection in 2012 the appropriate SOPs were still found in draft status.

andyouandme

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清歌一曲月如霜

andyouandme 发表于 2014-7-25 11:45
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让你批量的看

清歌一曲月如霜

andyouandme 发表于 2014-7-25 11:45
批量转移啊。。。。。。。。。。

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andyouandme

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andyouandme

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清歌一曲月如霜

andyouandme 发表于 2014-7-26 09:33
继续顶，让大家看看脸皮厚的家伙

你放p.......

清歌一曲月如霜

andyouandme 发表于 2014-7-26 09:33
假货，装不下去了

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