本文中观点不代表任何公司和组织，如有觉得有冒犯的地方，请于后台联系，我会及时删除。所有分享案例都具有孤立性，仅供参考。
受检机构/公司：The City College of New York/CUNY
受检地址：New YorkNY 10031
受检身份：生物检验机构
FEI号：3006508031
检查员：Sheri L.. Siephenson，Scongeun Cho，Melkamnu Getie Kebtie
检查日期：2022-09-14 至 2022-09-16
签发日期：2022-09-16
西门的吐槽：
数据完整性是什么，SM高层的支持，全体的参与，使用经过计量和验证的设备/系统，在遵守体系流程的情况产生足够的数据，可以复现所有的GXP业务。有时候有些地方，不需要数据完整性，也可能是可以的吧。
以下所有内容，摘自EIR
The City College of New York/CUNY
纽约市立学院(TheCity College of New York,缩写CCNY),或作“纽约市立大学城市学院”,成立于1847年,是纽约市立大学系统中的一所四年制学院,是纽约市立大学系统的创始学校
FEI: 3006508031
The inspection team was scheduled to arriveon 09/12/2022 at 9 :00 AM at the inspection site of Dr. Wang's office andlaborato1y, located at the CUNY Center for Discove1y and Innovation, 85 St.Nicolas Terrace, New York, NY 10031. I (SLS) arrived at the site first, atapproximately 8 :5 5 AM and approached the east entrance of the building wherea guard desk with gate-controlled access included instructions for providingCOVID vaccination status or negative COVID test documentation. I identifiedmyself to the security guard, showed my credentials, and explained I was thereto conduct an inspection and that I did not have a COVID vaccination ID card ora recent negative test result. Two additional security guards arrived onsiteand escorted me in an official vehicle to the campus administration buildinglocated at 160 Convent Avenue, Room 200, New York, NY 10031, to meet with theschool's "legal office."
视察小组计划于2022年9月12日上午9 :00抵达位于纽约市圣尼古拉斯露台85号纽约市立大学探索与创新中心的王博士办公室和实验室视察现场，邮编:10031。我（SLS）首先到达现场，大约在上午8 :5 5左右，来到大楼的东入口，那里有一个门禁门卫台，上面有提供冠状病毒肺炎疫苗接种状态或冠状病毒肺炎阴性检测文件的说明。我向保安表明了自己的身份，出示了证件，并解释说我是来进行检查的，我没有冠状病毒肺炎疫苗接种身份证或最近的阴性检测结果。另外两名保安赶到现场，用一辆官方车辆护送我到位于纽约州纽约市修道院大道160号200室的校园行政大楼，与学校的“法律办公室”会面。
………
Mr. Occhiogrosso then excused himself fromthe room and stated he would return in a few minutes. Approximately three to four minutes later, hereturned with two security guards, stated that he would not consent to ourinspection without a warrant or subpoena, then instructed the guards to escortus out of building.奥基奥格罗索先生随后离开了房间，并表示他将在几分钟内回来。大约三到四分钟后，他带着两名保安回来了，声称没有搜查令或传票他不会同意我们的检查，然后指示保安护送我们离开大楼。
OBJECTIONABLE CONDITIONS AND MANAGEMENT'SRESPONSE
1. 研究中使用的ELISA检测方法未经验证。具体而言，该中心使用了市售ELISA试剂盒，而没有对检测参数进行内部验证/确认。例如方法的准确度、精密度和灵敏度。
Respond:支持证据和相关性:根据王博士的说法，该工厂没有对ELISA检测进行任何验证或确认实验。有必要对ELISA检测进行验证或确认，以确保用于检测经审核研究的脑脊液样本中xxx的检测准确、灵敏且具有适当的精度。
Discussion with Management: Dr. Wang stated that he performedthe assays per the instruction sheet that came with each of the ELISA kits anddid not provide any justification why validation or verification of the assayswas not performed.
2. 用于ELISA检测的曲线拟合模型不充分。具体而言，该机构使用线性回归模型拟合了校准标准数据，但使用ELlSA分析测量的分析物的对数转换浓度-响应关系是非线性的，因此导致样品浓度测定不准确。
Respond:
Supporting Evidence and Relevance: Our review of thecalibration curves used in the ELISA assays revealed that the site fittedlog-transformed concentration-response data to a linear regression model whenthe relationship between the concentration and response data was clearlynon-linear. Examples include linear regressions that the site generated, for xxx(Exhibits 9-11). Dr. Wang told us that the site did not evaluate other curve fittingmodels to determine which model fits the data best.
Respond:
Discussion with Management: Dr. Wang stated that he usedthe only available curve fitting model in the software that he used (GraphPadin Prism version 5), which was linear regression, and that he did not know ofthe existence of other models in the software. We discussed with Dr. Wang thatbecause the concentration-response plots for the audited study appearnon-linear, the currently used linear regression model would result ininaccurate dete1mination of sample concentrations. As stated elsewhere in theEIR, although he was receptive of our comment to explore other curve fittingmodels and re-calculate the concentration data using the best curve fit, Dr.Wang did not provide any new data up until the time we closed the inspection on9/16/2022.他不知道该软件中存在其他模型。尽管王博士接受我们的意见，探索其他曲线拟合模型并使用最佳曲线拟合重新计算浓度数据，但直到我们于2022年9月16日结束检查时，他仍未提供任何新数据。
3. 没有足够的原始记录来重建这项研究。具体来说。该机构没有维护:样本存储和跟踪的记录实验程序的记录（例如，样本移除/返回记录、校准标准的制备、样本等分、与ELISA和蛋白质印迹操作相关的过程）蛋白质印迹分析的原始记录ELISA检测中使用的酶标仪（多模式检测器软件）的审计追踪
Respond:
Supporting Evidence and Relevance: In conversations we hadwith Dr. Wang throughout the inspection it was revealed that the site did notmain ta.in sufficient documentation throughout the study conduct that allowsfor verification and reconstruction of critical activities.发现该场所在整个研究过程中没有提供足够的文件来验证和重建关键活动。
Discussion with Management: Dr. Wang acknowledged thisobservation and stated that he wasn't aware of the need to document theseactivities.并表示他不知道有必要记录这些活动。
4. 在以下分析物和样品的ELISA检测中，在确定平均样品浓度时，该中心从三次分析中排除了三个浓度数据中的一个数据，且无正当理由。
a.Xxx for samples: 03-001-0,04-009-0, 06-008-0, 10-001-0, and 13-016-0
b.Xxx for samples: 04-007-28,06-005-28, 07-008-28, 13-013-2g, and 10-004-28
c.Xxx for samples: 04-007-28.06-005-28, 07-008-28, and 13-013-28
d.Xxx for sample 04-007-28
Respond:
Supportingevidence: During review of the spreadsheets where calculated concentration dataare provided, we noted that, for some of the analytes, one of the threeconcentrations (i.e., triplicates) was excluded from calculation in determiningthe average sample concentration. Additional details and supporting evidenceare provided under "Data acquisition and processing" above.
支持证据:在审查提供计算浓度数据的电子表格期间，我们注意到，对于某些分析物，在确定平均样品浓度时，三种浓度中的一种（即一式三份）被排除在计算之外。更多详细信息和支持证据在上文“数据采集和处理”中提供。
Discussion withmanagement: Dr. Wang acknowledged this finding and explained that thoseexcluded values were not meant to be excluded, but rather due to a mistake increating an Excel formula for group 1, which was then carried over to othergroups by cutting and pasting the erroneous formula, causing the same mistakerepeated in all five groups. Dr. Wang stated that he corrected all thecalculation errors and submitted the updated data to xxx via email.他纠正了所有计算错误，并通过电子邮件向xxx提交了更新的数据。
5. 对于研究中使用的ELlSA检测，在样品分析过程中不包括质量控制样品来确定运行验收。
Respond:
Supporting Evidence and Relevance: Dr. Wang acknowledgedthat QC samples were not included in the assay plates to determine run/plateacceptance.
Discussion with Management: We explained to Dr. Wang theimportance of QC samples in bioanalysis, and he stated that he understood theneed for including them in the future.
6. 该中心没有进行稳定性评估以确保研究样本中分析物的测量结果准确。
Respond:
Supporting Evidence and Relevance: The site could notprovide any documentation of stability assessments. Dr Wang stated that his labdid not conduct an stability tests. He stated that he asked xxx whetherstability tests were performed, but xxx did not provide him information to his inquiry.
Discussion with Management: During the inspection, we askedDr. Wang if his lab has conducted any stability assessment to support thesample shipment, storage, and handling conditions for the CSF samples in theaudited study. He answered no. During the closeout meeting, he acknowledged theobservation.样本运输、储存和处理条件。
7. 与研究中使用的ELISA酶标仪和细胞计数仪连接的计算机没有访问控制（无用户登录要求）。
Respond:
Supporting Evidence and Relevance: During our inspection ofthe facility, we witnessed that computers connected to the plate reader and theimage scanner do not require password to log-in. Dr. Wang stated that there isno log-in requirement in place to access the operating system of these computers.We expressed our concern to Dr. Wang that, due to lack of access control to thecomputers, data security may not have been ensured. In addition, we mentionedthat lack of log-in information would prevent us from verifying a user whoacquired the data, which is important information to reconstruct the study.我们见证了连接到酶标仪和细胞计数仪的计算机不需要密码即可登录。王博士表示，访问这些计算机的操作系统不需要登录
Discussion with Management: Dr. Wang stated that data fromthe plate reader and image scanner were directly saved into USB drives and nodata were stored in the computers. During the closeout meeting, Dr. Wangacknowledged this observation.酶标仪和细胞计数仪的数据直接保存在U盘中
8. 在样品分析期间，该中心没有校准主要设备（例如Multimode Detector DTX 880和-80°C冰箱，ID #045299），或者无法提供仪器校准和维护文件。
Respond:
Supporting Evidence and Relevance: During our inspection ofDr. Wang's laboratory on 09/14/2022, he stated, while we were examining thefreezers, that none of the freezers had been calibrated and there were nocalibration records. While the inspection team observed Dr. Wang'sdemonstration of the operation of the DTX 880 plate reader, we noted thecalibration sticker on the machine showed a date of "2019," the yearof the last calibration. Dr. Wang stated that the DTX 880 had not beencalibrated since then and he stated he did not have any calibration records.没有一个冰箱经过校准DTX 880一直没有校准
Discussion with Management: Dr. Wang stated he wasn't awareof the requirements for calibration, and he will ensure that calibrations areattained and maintained going forward.王博士表示他不知道校准的要求，他将确保校准的实现和保持。
