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1、PDA TR 80制药实验室数据完整性管理体系（中英文对照版） 原标题：PDA TR 80制药实验室数据完整性管理体系（中英文对照版）PDA TR 80制药实验室数据完整性管理体系现已全文翻译完毕，大家可以点击文末“阅读原文”链接下载中英文对照版全文。由于微信篇幅关系，这里只放出微生物实验室数据完整性的内容：5.0 Data Integrity in the Pharmaceutical Microbiology Laboratory5.0 微生物实验室的数据完整性5.1 General Considerations and Risks一般原则及风险The approaches used to
2、 investigate the occurrence of suspected data integrity issues that h recently occurred in a pharmaceutical microbiology laboratory can be challenging and, in some cases, may be very different than those used to evaluate similar occurrences in an analytical chemistry laboratory, Many microbiological
3、 methods are performed manually;subsequently, the recorded results are often based on the visual observations by an individual scientist performing the tests.制药企业微生物实验室对可疑数据完整性问题的调查方法，越来越成为一个挑战，并且在一些情况下，与同样发生可疑数据的化学分析实验室的调查方法完全不同。很多微生物测试方法都是手动操作，以及所有的测试结果都由微生物测试人员人工检查并记录。Listed below are a few examp
4、les of regulatory observations, Warning Letters, or other institutional accounts that note data integrity problems associated with microbiological laboratory records. These are only examples and are not intended to be an all-inclusive list of concerns:以下是一些官方检查项，警告信，或其他官方检查关于微生物实验室记录数据完整性问题的情况列举，这些仅
5、是举例并不完全代表所有与微生物实验室数据完整性相关的问题：Company failed to record and report reliable and accurate data for the environmental monitoring (EM) results; for example, contamination in Grade A rooms were recorded and reported as having no viable microorganisms present when, in fact, microbial contamination was pres
6、ent. Specifically, the settle agar plates used in these areas were felsely reported as having “ no colonies present” but were found to contain 16 colony-forming units (CFU), more than could be reasonably overlooked.公司未记录和报告真实准确的环境监测结果数据；例如，A级区实际存在微生物污染但实际记录和报告为零。特别是A级区沉降菌报告为“无菌落生长”，但实际上发现沉降菌结果为16cfu
7、，可能会有更多类似的情况被掩盖。Company failed to implement an adequate quality assurance system as evidenced by: product sterility test failures that occurred and were not reported, investigated, or documented; five batches of viral harvests that were rejected due to contamination，yet no reports were initiated；and
8、 a company practice that product sterility test failure(s) were investigated only if more than one test jar per batch of the first or second harvests failed for sterility.公司质量保证体系未有效执行，具体表现为：产品无菌测试失败未报告，调查或记录；5批次产品由于病毒污染而被拒绝放行，但没有任何调查报告被发起，以及某些公司仅在第二次无菌失败或同一批次超过一瓶出现无菌样品失败的情况下，才会发起无菌调查Company used a
9、contract laboratory to perform microbiological testing; however, the company audit checklist used to evaluate the suitability of this laboratory was completed by the contract laboratory, not the company, with no follow-up verification.公司存在委托实验室进行微生物检测的情况，然而，对委托实验室符合性审计的主体是由该委托实验室进行而非公司，且并未进行任何确认。Pri
10、vate testing laboratory claimed to have conducted microbiological testing, yet it did not have the laboratory equipment (i.e., incubators) and/or media necessary to perform the analysis.公司声称内部进行微生物实验测试，但实验室并没有实验相关的设备（如培养箱）和/或测试所必须使用的培养基。Company used an “ unofficial” notebook to record microbial cont
11、amination in the plants water system; however, there was no official investigation or documentation regarding the water system contamination with a known pathogen (Pseudomonas aeruginosa).Comment: This type of observation relates to both the microbiology laboratory and operators behaviors. Periodica
12、lly, deceptive individuals will use the same technique to mislead, misrepresent, and/or obscure emerging microbial problems in manufacturing equipment that can impact product quality.公司使用“非正式”的记录本以记录工厂内水系统的微生物污染情况；然而，当发现水系统中存在已知控制菌（铜绿假单胞菌）污染时，公司并未针对此污染情况发起任何正式的调查或记录。Company recorded results that the
13、 growth promotion test on the media used for simulation studies supported growth meeting the standard set by USP Chapter Sterility Tests when, in fact, the microorganisms did not grow (30). In another case, filamentous fungi were seen growing in all five spiked media tubes, indicating contamination,
14、 yet laboratory records claimed that all five distinct species of microorganisms were actually growing per the USP standard.公司记录用于培养基模拟灌装的培养基促生长测试结果符合USP无菌检测章节的标准菌种生长要求，然而事实上，XX（30）微生物并未生长。另一个情形中检查人员发现，真菌菌丝在5管液体培养基试管中生长，显示了污染，但实验室记录却显示按照USP标准5管试验管中显示各测试菌种生长良好。Again, while this list is not exhaustive
15、, it does present actual inspection observations made by several regulatory auditors during their documentation of data integrity anomalies in pharmaceutical microbiology laboratories.虽然以上显示的清单并不详尽，但却来源于多次官方审计检查中微生物实验室存在的缺陷检查记录清单。5.1.1 Interviewing Analysts问询分析人员One critical element in conducting an
16、 audit for data integrity problems in a microbiological laboratory is interviewing the individuals who perform the QA/QC tests, in particular, the laboratory analysts or technicians. When reviewing analytical results reconded on worksheets or data printouts from the LIMS, for example, it is extremely difficult to detect data that shou
