2019.07.04日，主管审核电子数据时，发现分析员奚露露于2019

On July 04, 2019, when the supervisor reviewed the electronic data, it was found that the analyst Xi Lulu entered the standard dilution multiple in the EXCEL calculation table of the relevant substance of the USP method of cytarabine detected on the Agilent 46 # instrument on May 16, 2019. The upper value is 6250, and the wrong input is 25000, which results in a small impurity detection result. All impurity results involving 12 batches of batches 1036-A190206 ~ 1036-A190212 and 1036-A190301 ~ 1036-A190305. <br><br>Analyst Xi Lulu was negligent in calculating the impurity EXCEL and entered the standard dilution factor in the table incorrectly, resulting in a small impurity detection result; and the second reviewer did not find the error, so the deviation is a human error. <br><br>1. This deviation is caused by human error. The standard dilution factor of cytarabine related substances was entered incorrectly, and the analyst was assigned to recalculate the impurity results. The original EXCEL data was discarded and retained, and the COA of 12 batches of US registered standards was reissued according to the corrected results, and the data on the LIMS was updated. Reissued 2 batches of Russian registration standards (1036-A190210, 1036-A190211) product COA (the relevant substance items are according to USP method). After recalculation, the related substance items all met the standard. This deviation has no effect on the sample quality evaluation. The European registration standard related substance EXCEL calculated during the same period is correct and unaffected, and the 12 batches of cytarabine involved in this deviation have not been sold. . 2. Review the analysis of the cytarabine project that analyst Xi Lulu has tested since taking up the job on August 28, 2018. There is no other standard dilution factor input error. Verify that the other products tested are calculated correctly, and no similar problems have been found. 3. Through random inspection of the reviewer Wang Hao ’s three reviews this year, no review errors were found. 4. Reviewing the experimental data of cytarabine in the past year, no similar problems were found. <br><br>1. The original EXCEL data of 12 batches of cytarabine are discarded and retained, and the impurity result is recalculated. <br>2. Reissue the COA of 12 batches of products registered in the United States according to the results of the correction and update the data on LIMS. Two batches of 1036-A190210 and 1036-A190211 COAs of Russian standards were reissued.<br>3. Train relevant personnel on the H0-SOP-72047 laboratory review audit management program version 00, emphasizing that reviewers need to carefully check whether the data transfer is correct. <br>4. Notify the customer of the reopened COA result.

On 2019.07.04, the supervisor reviewed the electronic data, found that the analyst LuLu in 2019.05.16 in Agilent 46 instrument to detect the relevant substances in the EXCEL calculation table of the aglycoside USP method, the standard dilution multiple error, the test record is 6250, misrepresented into 25000, resulting in the detection of small impurities. All impurity results in 12 batches involved in batch 1036-A190206-1036-A190212, 1036-A190301-1036-A190305. <br><br>Due to the negligence of the analyst LuLu in calculating impurities EXCEL, the standard dilution multiple in the table is miscarried, resulting in the detection of impurities is small, and the second reviewer did not find the error, so the deviation is an artificial error. <br><br>1. This deviation is caused by human error. A glycosine related substance standard dilution multiple is misplaced, assigned analysts to recalculate impurity results, the original EXCEL data is invalid, according to the results of correction reissued the United States registration standard 12 batches of productCOA, and THE DATA on THE LIMS update. Reissue the COA of the 2 batches of The Russian Registration Standard 2 (1036-A190210, 1036-A190211) products (the relevant substance items are based on the USP method). After recalculation, the relevant substance items are in line with the standard, this deviation has no effect on the sample quality evaluation, the same period of calculation of the European registration standards related to the substance EXCEL correct, unaffected, and the deviation involved in 12 batches of alystosin are not sold. 2. Recall that the analyst Yan Lulu since the induction of 2018.08.28 has been tested for the alyssalysin project, there is no other standard dilution multiple transmission error phenomenon, verification of its detection of other products are calculated correctly, no similar problems were found. 3. Through spot checks and review of the three reviews of the experiment, none of the phenomenon found to be a review error. 4. Reviewing the experimental data of aglycine in the last 1 year, no similar problemwas were found. <br><br>1. The original EXCEL data of 12 batches of aglycine was invalidated and the impurity results were recalculated.<br>2. Reissue the COA of the 12 batches of u.S. registration standard signed standard according to the results of correction, and update the data on the LIMS. Reissue the Russian standard 2 batches of 1036-A190210, 1036-A190211 productcoA.<br>3. Training of relevant personnel H0-SOP-72047 laboratory review audit management procedure 00 version, emphasizing that the reviewer needs to carefully check whether the data transfer is correct.<br>4. Notify the customer of the re-opened COA results.

On July 4, 2019, when the supervisor reviewed the electronic data, it was found that Xi Lulu, an analyst, had misinput the standard dilution multiple in the excel calculation table of the relevant substance of cytarabine USP method detected on Agilent 46 instrument on May 16, 2019, which was 6250 in the test record and 25000 in the wrong way, resulting in the small impurity detection result. All impurity results of 12 batches of 1036-a190206 ~ 1036-a190212 and 1036-a190301 ~ 1036-a190305 are involved.<br>Due to the negligence of analyst Xi lulu in the calculation of impurity excel, the standard dilution multiple in the table was input wrongly, resulting in a small impurity detection result; and the second reviewer did not find the error, so the deviation belongs to human error.<br>1. This deviation is caused by human error. The standard dilution times of cytarabine related substances are wrongly input, the analyst is assigned to recalculate the impurity results, the original Excel data is invalid and retained, and the COA of 12 batches of products of American registration standard is reissued according to the corrected results, and the data on LIMS is updated. Reissue COA of two batches of Russian registration standards (1036-a190210, 1036-a190211) (relevant substance items shall be in accordance with USP method). After recalculation, all the items of related substances meet the standard. This deviation has no impact on the quality evaluation of samples. The European registration standard related substance excel calculated at the same time is correct and unaffected, and the 12 batches of cytarabine involved in this deviation have not been sold. 2. Review the cytarabine project inspected by analyst Xi Lulu since he took up his post on August 28, 2018. There is no other error in the standard dilution multiple. Check that the other products tested are correctly calculated and no similar problems are found. 3. No recheck error was found in the three rechecked experiments conducted by Wang Hao. 4. Reviewing the data of cytarabine in recent one year, no similar problem was found.<br>1. The original Excel data of 12 batches of cytarabine samples were discarded and retained, and the impurity results were recalculated.<br>2. According to the corrected results, 12 batches of American registration standards COA will be issued again, and the data will be updated on LIMS. The COA of two batches of 1036-a190210 and 1036-a190211 products in Russian standards was reissued.<br>3. Train relevant personnel on h0-sop-72047 laboratory review and audit management procedure version 00, emphasizing that reviewers need to carefully check whether data transfer is correct.<br>4. Inform the customer of the reopened COA results.