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受检机构/公司：AmbioPharm，Inc
城市：1024 Dittman Ct
类型：Peptide-drug substance Manufacturer 肽原液制造
FEI号：3006446551
Observation 1-PAI
Investigations conducted by your QC laboratory on out-of-specification results repeatedly determined that the results obtained were invalid and re-tested samples to achieve the chromatographic profile and expected resolution for the assay and impurity tests for xxx-drug substance, and xxx drug product, analyzed according to test methods.
您的QC实验室对不合格结果进行的调查反复确定所获得的结果无效，并对样品进行重新测试，以获得根据测试方法分析的xxx原料药和xxx药品的含量测定和杂质测试的色谱图和预期分离度。
Most of the investigations concluded that the chromatographic system, column, resolution, and integration parameters were the most likely causes of the failed outcomes. Those have been currently added to your test methods.
大多数调查得出的结论是，色谱系统、色谱柱、分离度和积分参数是最有可能导致不合格结果的原因。这些已经被添加到你的测试方法中。
As an example,
举个例子,
ØOn 02/10/2022, batch tests xxx and xxx reported atypical trial results. Although the chromatographic data was reprocessed, to improve maximum integration, the data was invalidated as it was run on a system that does not provide the expected quality.
2022年2月10日，批次测试xxx和xxx报告了非典型试验结果。尽管重新处理了色谱数据以提高最大积分，但由于数据在未提供预期质量的系统上运行，因此数据无效。
西门注释：晦涩，是指验证失效？
ØOn xxx new samples were prepared and analyzed for batches xxx and xxx that gave out-of specification Assay results for lot xxx
在xxx，制备并分析了批次xxx和xxx的新样品，这些样品给出了批次xxx的不合格分析结果
ØOn 04/28/2022, new preparations of same batches were analyzed on a different chromatographic system, but the data were invalidated due to an inconsistent peak profile.
2022年4月28日，在不同的色谱系统上分析了相同批次的新制剂，但由于峰形不一致，数据无效
西门注释：这里的留有挺扯，峰形不一致，为什么会在不同色谱分析软件上测试？
ØNew preparations were analyzed on 05/10/2022 obtaining chromatographic parameters and acceptable test results considered valid.
2022年5月10日对重新制备的样品进行了分析，获得了被认为有效的色谱参数和可接受的测试结果。
In addition, your QC lab does not have enough controls to handle test data in real time. Multiple cases were reported where test data was left undocumented and unverified for several weeks, leading to the preparation of new samples from the same batches.
此外，您的QC实验室没有足够的质控品来实时处理测试数据。报告了多个案例，在这些案例中，测试数据被搁置数周而未被记录和验证，导致从相同批次制备新样本
西门注释：这里的control没懂是质控还是控制措施，看懂的老师，可以留言告知
