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本帖最后由 沁人绿茶 于 2015-2-13 06:26 编辑
What does the FDA expect from Third Party Auditors and Consultants?
关于数据完整性的警告性：FDA期望第三方审计官和顾问做点什么？
In some of the Warning Letters from fiscal year 2014 seriousdeviations with regard to the handling of electronic data (e.g. datamanipulation) are listed. Typically, you can findin the Warning Letters the following statements: 2014财年的一些警告信中列出了一些关于电子数据处理的严重偏差（例如数据的不当处理）。在警告信中，你可以看到以下表述： l Yourfirm failed to ensure that laboratory records included complete data derivedfrom all tests necessary to assure compliance with established specificationsand standards (21 CFR 211.194(a)). [backcolor=rgba(255, 255, 255, 0.8)]你们公司没有确保实验室记录包含来自于为了确保符合确立的标准的所有测试的完整数据(21 CFR 211.194(a)). l Yourfirm failed to exercise appropriate controls over computer or related systemsto assure that only authorized personnel institute changes in master productionand control records, or other records (21 CFR 211.68(b)). 你们公司没有对电脑或者相关系统采取适当的措施来保证只有经授权批准的人员才能启动对主生产和控制记录或者其它记录的变更(21 CFR 211.68(b)). l Your firm frequently performs “unofficial testing” of samples,disregards the results, and reports results from additional tests. 你们公司经常进行样品的“非正式测试”，不管这些结果，并且报告另外测试的结果。 l The inspection revealed yourfirm’s use of scratch paper containing critical manufacturing data. The dataon these scratch paper records did not always match the data on thecorresponding official batch records... 检查发现你们公司使用的草纸包含着关键的生产数据。而这些草纸上的数据并不是总是与正式的记录上的数据一致。 These quotations are taken from 4 Warning Letters which were alladdressed to Indian pharmaceutical companies (please find here as an example aWarning Letter from February 2014). The GMP deviations detected during inspectionswith regard to electronic data are so elementary that the FDA urgently recommendsto the companies concerned to occasionally get a Third Party Auditor who wouldfirst perform an in-depth GMP audit and then support the company remove thedeficits with respect to data integrity. The consultants should be experts in this area. 这些内容来自于4封警告信都是发给印度制药公司的。检查中发现的关于数据完整性的GMP偏差是如此初级以至于FDA急切的建议涉及的公司偶尔请第三方审计官来先进行深度的GMP检查，然后协助公司改正关于数据完整性的缺陷。顾问必须是领域内专家。 In the Warning Letters mentioned, the FDA defines which servicesthe consultant has to bring ("Your data integrity expert should..." ). These requirements are largely identical in the 4Warning Letters and consist of the following measures: 在上述警告信中，FDA确定了顾问需要带来的服务（你们的数据完整性专家应…..）这封警告信中的要求大致相同，包含以下措施： l Gapless identification of all time periods where electronic datahave been recorded and documented incorrectly. 要能全部识别出所有时间段内被错误记录的电子数据。 l Identification and interview of all employees who were employed atthe site before, during, or shortly after these time periods. Activitiesin connection with systems, procedures and behaviour of the management whichcontributed to or caused the GMP deviations while handling electronic data shouldbe detected. 识别并审核该场地在这些时间段之前、之中、之后不久雇佣的所有人员。应能发现与系统、程序相关的活动，以及管理层在处理电子数据时可能促成或导致GMP偏差的行为。 l Employees who left the company before, during, or shortly afterthese time periods should also be interviewed accordingly. 在这些时间段之前、之中、之后不久离职的雇员也应该相应的审核。 l Additional supportingindications of GMP non-compliant handling of electronic data should beidentified. The involvement of other sites should be takeninto consideration. 应能发现不合规的处理电子数据的其它支持性证据。也要考虑其它场地是否涉及。 l The managers in chargeduring the time periods in question have to be identified by means oforganigrams and SOPs. It must be revealed to what extent the top andmiddle management knew about or was involved in the data manipulation. 要通过组织机构和SOPs确定在有问题的这些时间段负责的经理们。必须确定高层和中层管理者了解或者介入这些数据违规操作的程度。 l The data integrity expert should find out whether managers whohave been identified this way are still able to have an influence on the integrityof GMP relevant data (also with regard to applications for marketingauthorisations). Internal reviews are to be extended to other siteswhich are known to be involved in violations of GMP-compliant handling of data. 数据完整性专家应该查明通过上述方法确认的经理们是否仍然能够影响那些上市许可申请相关的数据。内审要扩展到其它的已知涉及到违规处理数据的场地。 For the auditor processing these points, the task is similar todetective work - which is likely to be demanding and not pleasant - as it maybe doubtful that he or she gets the fullest support from the company concerned. Yet,this detective work is essential in the interests of patient safety and istaken very seriously by the FDA, especially with Indian companies as the Agencydoesn't rely on their capability to resolve the data integrity problems withoutexternal support. 进行上述工作内容的审计官的任务与侦探工作相似-要求很高并且不受欢迎-因为他/她是否能从相关公司得到全力支持可能是值得怀疑的。然而，这些侦探型的工作对于病人的安全很重要，FDA很重视，特别是对于印度公司，FDA不相信他们能够单单依靠自己的力量不用外力来解决数据完整性问题。
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发表于 2015-2-12 23:01:13
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