通过调查，此次偏差涉及的盐酸罗格列酮，是由于相关人员未按照中间体取样操

Through the investigation, the rosiglitazone hydrochloride involved in this deviation was caused by the incorrect batch number on the rosiglitazone hydrochloride inspection form due to the failure of the relevant personnel to follow the intermediate sampling operating procedures (document number: H3-SOP-61042). No effect on the quality of the sample itself. <br>QC's microbial limit detection for crude products is based on the rosiglitazone hydrochloride microbial detection method (document number: H0-AM-20085-04). The batch number error has no effect on the test results. <br>See: D-TZ-API-11RO-21001-R for details.

Through investigation, rosiglitazone hydrochloride involved in this deviation was due to the related personnel's failure to operate according to the intermediate sampling operation procedures (Document No.: h3-sop-61042), which caused the wrong batch number in the application form of rosiglitazone hydrochloride, and had no impact on the quality of the sample itself.<br>The microbial limit of the crude product was detected by QC according to the microbial detection method of rosiglitazone hydrochloride (file No.: h0-am-20085-04), and the error of batch number had no effect on the detection results.<br>See d-tz-api-11ro-21001-r for details.<br>

According to the investigation, rosiglitazone hydrochloride involved in this deviation is due to the wrong batch number on the inspection form of rosiglitazone hydrochloride caused by the failure of relevant personnel to operate according to the intermediate sampling operation procedures (document number: H3-SOP-61042), which has no impact on the quality of the sample itself.The microbial limit test of QC for crude products was carried out according to the microbial test method of rosiglitazone hydrochloride (file number: H0-AM-20085-04), and the wrong batch number had no effect on the test results.See D-TZ-API-11RO-21001-R for details.