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来源:网络 作者:TH 发表时间:2018-08-23 浏览:2866

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 


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


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).


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.


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.


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,澳门新葡游戏网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。


企业名称:印度Alkem Laboratories


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.



企业名称:米尼加Labocont Industrial SRL 20180309


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.


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.



企业名称:印度Alchymars ICM SM Private Limited


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


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.


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.


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.


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.


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.



企业名称:韩国Cosmecca Korea Co., Ltd.


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.

澳门新葡游戏网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。


企业名称:印度Keshava Organics Pvt. Ltd


Failure to maintain complete laboratory control records for test methods.


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.



企业名称:韩国Cosmecca Korea Co., Ltd.


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.





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


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.



企业名称:印度Alkem Laboratories


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.


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