320-18-47 云南丽江映华

翻江鼠

警告信编号	320-18-47
检查公司	云南丽江映华
检查时间	2017年10月16-20日
缺陷项
1.    Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. 对计算机化系统未进行充分控制以防止未经授权进入或修改数据。 Laboratory equipment used to generate analytical data for batch release purposes by your quality unit lacked restricted access. For example, the high-performance chromatography (HPLC) and gas chromatography systems each had a single username with administrator rights. All users could delete or modify files, and there was no mechanism to trace individuals who may have created, modified, or deleted data generated by computerized systems. 用于生成质量部门提请批放行的分析数据的化验室设备缺少权限控制。例如，HPLC和GC系统，所有人都共用一个具有管理者权限的用户名。所有用户都可以删除或修改文件，没有机制追踪经由计算机化系统创建、修改或删除数据的个人信息。 In your response to a previous FDA inspection conducted March 30 to April 3, 2015, you committed to: 在你们对之前2015年3月30日至4月3日的FDA检查回复中，你们承诺： enabling the audit trail function on laboratory electronic instruments; 激活化验室电子仪器上的审计追踪功能； assigning unique user names and passwords for each staff member; and 为每个员工赋予单独的用户名和密码，以及 authorizing (b)(4) levels of accessibility to prevent electronic data from being deleted, removed, transferred, renamed or altered. 授权XX个权限级别以防止电子数据被删除、清除、转移、重命名或修改。 In the October 2017 inspection, our investigatorobserved that you had not implemented any of these promised corrective actions. 2017年10月的检查中，我们的调查人员发现你们并未实施所承诺的纠正措施。 2.      Failure to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards. 为确保你们API和中间体符合既定规格和标准所实施的所有化验室检测中所生成的完整数据未得到保存。 Your firm performed HPLC assay testing for (b)(4)API release to the United States, along with stability and intermediate testing, on your Waters HPLC system between September 25, 2011, and May 5,2017. Official quality control data packages presented to the quality unit for batch disposition decisions reported the results of testing performed during this timeframe on this equipment. During our inspection, when we sought to reconcile assay results reported in the quality control data package for areleased batch with the underlying electronic data, you responded that you could not provide the electronic data from laboratory analyses on this equipment for the above period of several years. You explained that the electronic data in question had been deleted by accident and was no longer available. 你们公司在2011-09-25至2017-05-05之间用WATERS HPLC系统对放行至美国的XX原料药进行了HPLC含量检测，以及稳定性和中间体检测。提交给质量部门用于批处置决策的正式QC数据包报告了在此设备上此时间段内实施的检测结果。在我们检查过程中，当我们搜寻与用于批放行QC数据包中报告的相同含量结果以及底层电子数据时，你们回答说你们无法从实验室在该设备的分析中提供上述几年的该电子数据。你们解释说这些电子数据已经意外地被删除了，再也找不到了。 In your response, you stated that the electronic data had been downloaded to a “mobile hard disk for backup” and that you would beable to recover the data after you have upgraded your HPLC software. However,you did not include evidence to support recovery of deleted electronic data or demonstrate how you will prevent such deletions from recurring in the future. 在你们的回复中，你们声称该电子数据已被下载至一个“备份移动硬盘”中，你们可以在升级了HPLC软件之后恢复这些数据。但是，你们并未包括有证据支持你们对已删除电子数据的恢复，或证明你们如何防止此类删除在将来重复发生。 3.      Failure to document, explain, and investigate any deviation from established procedures. 未能记录、解释和调查所有偏离既定程序的偏差。 During the inspection, our investigator reviewed the electronic HPLC injection history for (b)(4) intermediate stability sample, batch (b)(4). The history indicated that the same vial was injected twice on June 14, 2017. The first injection was not included in the final data packet provided to the quality unit for batch review, and the intermediate batch was ultimately cleared for and used in manufacturing a finished lot of (b)(4) API, batch (b)(4). 在此次检查中我们调查人员审核了XX中间体XX批号稳定性样品的电子HPLC进样历史。该历史显示相同样品瓶在2017年6月14日进样2次。第一次进样未包括在提交给质量部门用于批审核的最终数据包里，中间体批最终放行并用于生产批次XX的原料药，批号为XX。 According to your quality control analyst, the first injection appeared abnormal because it did not show a peak at the expectedretention time. The second injection, within specification, was used to releasethe batch. There was no documentation, explanation, or investigation of theabnormal result of the first injection. 根据你们QC化验员的说法，第一次进样显示不正常，因为在预期的保留时间内未出峰。第二次进样在质量标准范围内，所以用于放行该批次。第一次进样的异常结果并无文件记录、解释或调查。 Our investigator also observed similar instances in which abnormal injections were disregarded without investigation. 我们的调查人员还发现异常进样被忽略且未调查的类似情况。 In your response, you stated that you conducted a deviation investigation of batch (b)(4) on October 21, 2017, and you started retesting retention samples of related batches at that time. Your response is inadequate because it lacks details of this deviation investigation.  It also lacks a comprehensive assessment and remediation of your overall system for investigations of deviations, atypical events,complaints, out-of-specification results, and failures. 在你们的回复中，你们声称你们在2017年10月21日对XX批次进行了偏差调查，你们对当时的相关批次开始进行留样复测。你们的回复是不充分的，因为它缺乏该偏差调查的详细内容，还缺乏对你们偏差调查、异常事件、投诉、OOS结果和失败全面系统的综合评估和补救措施。 4.      Failure of your quality unit to review and approve all appropriate quality-related documents.你们质量部门未审核和批准所有与质量有关的文件。 Your quality unit approved the certificate of analysis(COA) for release of an API batch to your customer before testing was completeand available for review. 你们质量部门在检测完成提交审核之前就批准了用于放行API批次的COA给你们的客户。 During the inspection, our investigator reviewed the COA for (b)(4) API batch (b)(4). Your quality unit reviewed and approved this COA on May 29, 2015. However, the test for related substances on this batch was not performed until May 30, 2015. During the inspection, your quality control manager explained that this specific COA had been released early to the quality unit because it was urgent and needed to be provided to your customer. 在我们的检查过程中，我们的调查人员审核了XX原料药批次XX的COA。你们质量部门审核和批准该COA的日期是2015年5月29日，但是，该批次有关物质的检测是在2015年5月30日才做的。在我们检查过程中，你们QC经理解释说这个特定的COA早一点签给质量部门是因为它很紧急，需要提供给你们的客户。 In your response, you summarized your standard operating procedures for testing, reviewing, and approving COA. Your response did not explain the reasons for this failure or indicate how your proposed revision to the reporting structure and approval procedures will prevent recurrence. 在你们的回复中，你们汇总了你们检测、审核和批准COA的标准操作程序。你们的回复并未解释此失败的原因，亦未说明你们提议的修改后报告结构和批准程序要如何防止其再次发生。

本文摘自 OurGMP

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