由于送样人姚海青未参照盐酸罗格列酮工艺再验证取样记录（文件编号：H3-

Since the sample sender Yao Haiqing did not refer to the rosiglitazone hydrochloride process to re-verify the sampling record (document number: H3-VD-50338-RVP-R01), fill in the sample label and stability check form, and did not change the sample label. Refer to the original sample label writing; the crude intermediate samples in normal production were not sent to the synthetic IPC for testing in time, so that the central control samples and stability samples of different batch numbers should be filled in the inspection form at the same time, resulting in batch 5020011N201004-05. Write the same batch number as the batch number on the 5020011N201001 batch. At the same time, the deputy director of the workshop Wang Rukui and API QA Zeng Shuping did not carefully check the sample batch number and sampling plan on the request form, which eventually led to the incorrect use of the sample batch number during API testing.

Yao Haiqing, the sample sender, failed to fill in the sample label and stability request form according to the sampling record of re validation of rosiglitazone hydrochloride process (file No.: h3-vd-50338-rvp-r01), and failed to refer to the original sample label when replacing the new sample label; The crude samples of intermediates in normal production were not sent to the synthetic IPC for testing in time, so that the application forms of central control samples and stability samples with different batch numbers were filled in at the same time, resulting in the same batch number written on 5020011n201004-05 batch application form and 5020011n201001 batch application form. At the same time, Wang Rukui, deputy director of the workshop, and Zeng Shuping, API QA, did not carefully check the sample batch number and sampling schedule on the inspection request, which eventually led to the wrong use of sample batch number in API testing.<br>

Yao Haiqing, the sample sender, did not fill in the sample label and stability inspection form with reference to the document of the process revalidation sampling record of rosiglitazone hydrochloride (DocumentNo.: H3-VD-50338-RVP-R01), and did not refer to the original sample label when replacing the new sample label; The crude intermediate samples in normal production were not sent to Synthetic IPC for testing in time, so that the application forms of central control samples and stability samples of different batches were filled out at the same time, resulting in the same batch number as the application forms of batch 5020011N201001-05 and batch 5020011N2001. At the same time, Wang Rukui, deputy director of the workshop, and Ceng Shuping of API QA did not carefully check the sample batch number and sampling schedule on the inspection requisition, which eventually led to the wrong use of the sample batch number during API inspection.