缺陷关键词：数据可靠性，原始数据 实验室记录

企业名称：印度Alkem Laboratories　

缺陷项描述：

Established laboratory control mechanisms are not documented at the time of performance.

在进行实验室检测时未未按既定的实验室控制机制进行记录。

Specifically, 具体来说

A. During our inspection of the QC laboratory on 19 March 2018, we observed your QC Analyst entering data electronically into an excel spreadsheet, in the absence of raw data. This same data was also entered into the 9M Stability Study Logbook for (b)(4) Tablets (b)(4)mg, Batch #(b)(4), manufactured April 2017 (2months late).

在2018-03-19我们对QC实验室检查期间，发现你们QC分析员将电子数据录入到一个EXCEL表格中，而没有原始数据。同样的数据亦被录入生产日期为2017年4月的XX片剂XX批号的9个月稳定性研究登记本(延迟2个月)。

B. On 23 March 2018, we observed a QC Executive reviewing an OOS/OOT investigation for (b)(4)mg Tablets, Batch#(b)(4) where the stability and scoring study were OOT. The employee had a pen for signing for the review, but no checklist, paper, or workstation for recording errors. In the event of an error the employee reported, they would notify the Section Head and Analyst, but not document it.

2018-03-23，我们发现一位QC经理正审核一份XX片剂XX批号的OOS/OOT调查，该稳定性和分级调查为OOT。该员工有一支钢笔用于审核签字，但并没有检查清单、纸或工作站来记录错误。在员工报告错误时，他们就口头通知分区领导和分析员，无纸质记录。

C. On 23 March 2018, we observed an Analytical Worksheet for Raw Materials for (b)(4), Batch#(b)(4), did not contain any data for the UV conducted on 13 March 2018. The QC Analyst that conducted this analysis stated he did not document these recordings on the Analytical Worksheet because his data packet was removed by other Analysts without his knowledge.

2018-03-23，我们发现一个XX产品XX批号原料的分析记录中并无2018-03-13所进行的UV检测数据。执行此检测的QC分析员声称他并未将这些记录在分析记录上，因为他的数据包在他不知情的情况下被别的分析员清除了。

D. On 22 March 2018, we observed a manufacturing employee entering tablets weights non-contemporaneously during the manufacturing of (b)(4) tablets USP (b)(4)mg, Batch#(b)(4) in the (b)(4) Block building.

2018-03-22，我们发现一位生产员工在XX车间生产XX批次的XXmg USP规格的XX片剂时，未同步录入片剂重量。

缺陷关键词：数据可靠性，实验室记录

企业名称：印度Alkem Laboratories

缺陷项描述：

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

实验室记录未包括为确保符合既定规格和标准而进行的所有测试、检查和含量中生成的完整数据。使用了电子记录，但它们无法确保其可信度、可靠度和等同于纸质记录的效力。

缺陷关键词：数据可靠性，检测记录

企业名称：米尼加Labocont Industrial SRL 20180309

缺陷型项描述：

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21CFR 211.194(a)).

你们公司未能确保实验室记录包括为确保符合既定质量标准所必须的所有检测项的完整数据(21 CFR211.194(a))。

Your firm does not ensure that complete data from assay testing of your finished drug products and active pharmaceutical ingredients(API) are maintained and reviewed by your quality unit. For example, our investigator observed that an analyst failed to document absorbance data generated during assay analysis, and only reported calculated results.

你公司未能确保制剂产品和API含量的完整检测数据由你们质量部门进行保存和审核。例如，我们调查人员发现一位分析员未记录含量分析中生成的吸收数据，仅报告了计算结果。

Because you do not document and maintain complete data from your analyses, it is not possible to evaluate whether the method was followed and data is valid, or to substantively investigate sources of deviations and variation in your laboratory. It is essential that all data generated during analysis is maintained and reviewed to determine whether laboratory procedures are followed, and raw materials and drug products conform to established specifications.

由于你们并未记录和保存来自分析的完整数据，因此无法评估是否遵循检测方法以及数据是否有效，也无法对你们实验室内的偏差和波动来源进行实质性调查。保存分析中所生成的所有数据并进行审核对确定是否遵循了实验室室程序，确定原料和药品是否符合既定质量标准是很重要的。

缺陷关键词：数据可靠性，设备维护记录

企业名称：印度Alchymars ICM SM Private Limited

缺陷项描述：

Failure to properly maintain equipment and to keep complete records of major equipment maintenance.

未能对设备进行妥善维护，并保存主要设备维护的完整记录。

Our investigator found damaged product-contact surfaces on your multi-product equipment. For example, the man hole gasket of (b)(4)111 was deteriorating and wrapped in peeling tape. A gasket on the (b)(4)102 was also cracked in one area and wrapped in peeling tape.

我们调查人员发现你们多产品生产设备与产品接触的表面受损。例如，XX111的人孔垫圈损坏，包裹在剥落的胶带中。XX102的垫圈也有一个地方裂开了，也是包裹在剥落的胶带中。

Your SOP/ENG/39-1, Gasket Management for Equipments and Pipelines which are in Direct Contact with the Product, section 4.18, requires you to replace gaskets in critical areas, including gaskets for (b)(4)111 and (b)(4)102, (b)(4). Your firm was unable to provide gasket replacement records for this equipment during the inspection.

你们的SOP/ENG/39-1“与产品直接接触的设备和管道垫圈管理”第4.18部分要求你们对关键区域的垫圈进行更换，包括XX111和XX102的垫圈。你们公司在检查期间未能提供该设备的垫圈更换记录。

Furthermore, the most recent records of your firm checking the condition of the gaskets for (b)(4)102 were from January 2017, more than (b)(4) before our inspection.

还有，你们公司检查XX102垫圈情况的最近记录是从2017年1月开始的，在我们检查之前XX时长。

This is a repeat observation from our February 2015 inspection. We also note that you have found deteriorating gaskets to be the root cause for finished API particle complaints.

这是2015年2月我们检查中发现的重复缺陷。我们也注意到你们已发现了老化的垫圈是成品原料药颗粒物投诉的根本原因。

Your response is inadequate. You stated that the “involved gasket was immediately substituted” but did not evaluate all other gaskets on your manufacturing equipment. You indicated that you will update your procedure to require a supervisor walk-through to assess product contact surfaces, but did not include sufficient detail(e.g. frequency of equipment inspection). You also failed to address the lack of gasket maintenance records.

你们的回复是不充分的。你们声称“所涉及的垫圈马上就被替换了”，但并未评估你们生产设备上所有其它垫圈。你们说你们会更新你们的程序，要求主管现场排查以评估产品接触表面，但并未包括足够详细的内容(例如，设备检查的频次)。你们也未解决缺少垫圈维护记录的问题。

缺陷关键词：数据可靠性，伪造实验室检测数据

企业名称：韩国Cosmecca Korea Co., Ltd.

缺陷项描述：

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards(21 CFR 211.194(a)).

你们公司未能确保实验室记录包括为确保符合既定质量标准所必须的所有检测项的完整数据(21 CFR211.194(a))。

Our investigator documented multiple examples of falsifying laboratory records. Your quality control laboratory employee stated that he fabricated laboratory data for untested finished drug products by manipulating electronic laboratory records. For example, he changed the file names for test results of previously tested drugs so that the file names appeared to reflect the results of other lots of product. Your firm used this falsified laboratory data to determine the strength of your OTC (b)(4) drug products. Your response stated that your quality assurance manager instructed laboratory analysts to manipulate, falsify, or fabricate data.

我们的调查人员记录下了多个伪造实验室记录的例子。你们的QC实验室员工说他通过捏造电子实验记录为未检测的药品伪造实验室数据。例如，他更改了之前检测药品的检测结果的文件名，这样该文件名看起来反映的是另一些批次药品的检测结果。你们公司使用这些伪造的实验室数据来决定你们OTC XX药品的剂量。你们在回复中声称说你们的QA经理指示分析员捏造、伪造或虚构数据。

缺陷项关键词：数据可靠性，检测数据

企业名称：印度Keshava Organics Pvt. Ltd

缺陷项描述：

Failure to maintain complete laboratory control records for test methods.

未能保存完整的实验室检验方法记录。

In several instances, you failed to maintain complete data for API tested and distributed to the U.S. For example, we found test data sheets with missing sample weights for identity testing, batch/lot numbers for reference standards and reagents, equipment identification, and complete thin layer chromatography data for related compounds.

在数个事例中，你们未能保存销往美国的API的完整检测数据。例如，我们发现检验数据表缺失了鉴别测试中的样品重量、对照品和试剂的批号、仪器编号，有关物质的完整TLC数据。

缺陷关键词：数据可靠性，计算机化系统，权限控制

企业名称：韩国Cosmecca Korea Co., Ltd.

缺陷项描述：

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

你公司未能对计算机和相关系统执行适当的控制以确保只有经过授权的人员才可以修改主生产和检测记录以及其它记录(21 CFR211.68(b))。

Laboratory equipment used to generate analytical data for release purposes lacked restricted access. For example, analysts shared usernames and passwords, and all users had administrator rights that permitted them to delete or modify files in high-performance liquid chromatography and gas chromatography equipment. You had no mechanism to facilitate traceability of the individuals who changed, adjusted, or modified data generated by computerized systems.

用于生成放行所需的分析数据的实验室设备缺乏权限控制。例如，实验室共用用户名和密码，所有用户都具有管理员权限，均可以删除或修改HPLC和GC仪器中的文件。你们没有机制来审计跟踪何人修改、调整或改动了计算化系统生成的数据。

缺陷关键词：数据可靠性，历史分析数据保存

企业名称：中国湖南新合新

缺陷项描述：

Failure to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.

未能保存所有为确保你们原料药和中间体符合既定标准而执行的实验室检测中生成的完整数据。

Your firm failed to retain and locate the analytical raw data for batches (b)(4) and (b)(4) of (b)(4)base which you shipped to the United States in 2014. In your response, you stated the “analytical data was not backed up.” You also said that you transferred the instrument that generated the data to your (b)(4) branch in 2015 and that the staff there deleted the data. It is essential to retain raw data to ensure the ability to reconstruct cGMP activities and review raw data, as necessary, for deviations and investigations.

你们公司未保存你们在2014年销往美国的XX基XX批和XX批的分析原始数据。在你们的回复中，你们声称“分析数据没有备份”。你们还说你们将生成这些数据的仪器于2015年转移至你们XX分部，那儿的员工删除了这些数据。保存原始数据以确保可以还原cGMP活动和在必要时如偏差及调查时对原始数据的审核是基本要求。

缺陷关键词：数据可靠性，网络存储数据的删除

企业名称：印度Alkem Laboratories

缺陷项描述：

A Your firm’s QC department deleted two-thousand one hundred one (2,101) files since 1March 2018 on your network. These files names include, but are not limited to: OOS, OOT, Incidents, Method Verification Reports, chromatographs, calculations, and Stability Reports.

你公司的QC部门自2018-03-01起从你们网络上删除了2101个文件。这些文件名称包括但不仅限于OOS、OOT、事件、方法确认报告、色谱、计算和稳定性报告。