欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
FDA官网发布对浙江海正警告信，签署日期为2015年12月31日。
英文原文下载：FDA官网http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480035.htm
翻译件参见附件，翻译内容转载请注明出自蒲公英。
摘录如下：
Our investigators observed specific deviations during the inspection, including, but not limited to, the following. 我们的调查员在检查中发现了一些问题，包括但不仅限于以下： 1. Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data. 未能防止不经授权获取或更改数据，未能提供充分的控制以防止数据被篡改及数据遗失。 During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data and paper records. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards. 在检查中，FDA调查人员发现缺失了基本的化验室控制，无法防止对贵公司电子存贮数据和纸质记录的更改。贵公司依赖于不完整的记录来评估你们药品的质量，决定你们的药品是否符合既定的规格和标准。 Our investigators found that your firm routinely re-tested samples without justification and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs. You are responsible for determining the causes of these deviations, for preventing recurrence, and for preventing other deviations from C GMP. 我们的调查人员发现贵公司经常对样品进行复试，而没有相关论证，并且将分析数据进行了删除。我们在你们整个工厂都发现有数据造假现象，包括多个化验员在多种药品多个检测设备上所做的事情。贵公司有责任确定这些问题的原因，以防止同样问题再次发生，以及防止其它偏离CGMP的问题发生。 a. During the inspection, we reviewed the electronic log for high performance liquid chromatography (HPLC) system #36 and determined that the audit trail was disabled on February 6, 2014. One of your analysts executed 80 HPLC injections for assay and impurity tests of validation stability batches (b)(4) of (b)(4) API. 在检查中，我们审核了36#HPLC系统的电子日志，确定2014年2月4日其审计追踪没有激活。贵公司一名化验员在当日进样80针，是某原料药某验证稳定性批次的含量和杂质检测。 Because the audit trail was disabled, neither your quality unit nor your laboratory staff could demonstrate that records for these batches included complete and unaltered data. All supporting raw data was discarded, including sample solution dilutions and balance weight printouts. Sample analyses were not recorded in the instrument use logbook. Test results were deleted from the hard drive and all supporting chromatograms were discarded. Audit trail functions were re-enabled on February 8, 2014, and the same analyses were repeated. You submitted the February 8th test results to the FDA in March 2014 in support of Drug Master File (DMF) (b)(4). 由于审计追踪被关闭，你们的质量部门和化验室员工都不能证明这些批次的记录包括的是完整未经伪造的数据。所有支持性原始数据均被弃去了，包括样品溶液稀释记录和天平称量打印纸。样品分析没有记录在仪器使用日志上。检验结果被从硬盘删除了，所有支持性色谱图均被废弃。审计追踪功能在2014年2月8日重新激活，然后重复了相同的样品检测。你们在2014年3月向FDA提交了2月8日的检测结果用以支持某原料药的DMF文件。 During the inspection, we asked the analyst who generated the data submitted to the FDA whether audit trails could be disabled. The analyst stated that another employee, who was no longer with the company, had disabled the audit trails. Your firm could not explain why the audit trail was disabled or why the original data was deleted, nor could you demonstrate whether the original results were within specification. 在检查中，我们就审计追踪是否可以关闭的问题询问了实施检测获得FDA申报数据的化验员。化验员说是另一名化验员关闭的审计追踪功能，但该名化验员已经离开了公司。贵公司不能解释为什么审计追踪会被关闭，也不能解释为什么原始数据会被删除，更无法证明原始结果是否符合质量标准规定。 In your response, you assumed that the original raw data was deleted because a system suitability failure invalidated the data. You acknowledged that the data should not have been invalidated without an investigation of the laboratory event. However, your response is inadequate. There is no evidence to support invalidation of the original data on the grounds of a system suitability failure because your firm deleted all of the original records associated with these analyses. 在你们的回复中，你们假定初始的原始数据是因为系统适用性失败导致结果无效才被删除的。你们承认不应该没有经过化验室事件调查即行宣布数据无效。你们的回复不够充分。没有证据支持你们关于“初始的原始数据是因为系统适用性失败导致结果无效才被删除的”的说法，因为贵公司已删除了那些样品分析的所有原始记录。
| 
[复制链接]
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2016-1-13 11:34:24
置顶卡
变色卡
发表于 2016-1-14 10:09:35
楼主
造假养成习惯了，故意造假罪加一等啊
)；却极少回复(18
)。
！