20140723 ECA新闻：每5封FDA警告信就包括一个关于设备的缺陷

20140723 ECA新闻：每5封FDA警告信就包括一个关于设备的缺陷 by julia翻译2014-07-28 蒲公英

原文网址：http://www.gmp-compliance.org/en ... ng%20Equipment_8428,8526,8427,9087,Z-PEM_n.html

GMP News
23/07/2014

Every fifth FDA Warning Letter includes deficiencies regarding Equipment

每5封FDA警告信就包括一个关于设备的缺陷

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.

所考虑的统计期间是从2012年到2014年第一季度，包括美国本土内外的公司。在所提到的19封警告信中没有单独因为设备缺陷导致警告信的，但是总体情况显示对FDA关于在用生产设备的要求缺乏理解。几乎每一起案例中，均引用了对21 CFR 211.67的违反情况（设备清洁和维护），例如缺乏维保体系或维保体系不满足要求。在一起案例中，发现生产用锅炉里有刮痕和生锈。在另一起案例中，药监局发现明显的设备状态缺陷，另外，缺少维保计划，生产用建筑物缺乏维保/清洁。还有一起案例中，发现常规校正不充分，甚至根本就找不到校正记录。

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.

同样，生产设备确认也是缺点列表中。例如，在一起案例中，FDA批评公司没有对片剂测试工作站（硬度、片重）在可能的不同速度设定下进行准确性检查，作为PQ的一部分。还有，在PQ中没有充分考虑在不同速度下压片后片剂弹出情况。在给中国大陆和中国台湾签发的两封警告信中，提到他们根本没有对生产设备进行确认。

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 with non-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.

在大多数情况下，警告信是在对检查后缺陷信首次回复不够充分情况下发出的。例如，在一起案例中，检查发现没有进行要求的校正，但公司的回复中缺少了使用该未经校正设备进行生产，且已上市相关批次的评估。在另一起案例中，受影响的是灌装线的维保和清洁，FDA期望的评估是要延伸到采用该灌装线生产的其它产品，同时要制主要新的维保和清洁计划，并提交这些计划有效性的声明。有点难以理解的是在另一个公司的案例中，公司已在2001年、2003年和2011年检查中均被发现其设备的维保和清洁中缺失或不充分，而在2012年新的GMP检查中，发现公司的SOP仍在起草状态。

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