2019.10.23日15：33，童万增在对Y50-04洁净区的相关记

On October 23, 2019 at 15:33, Tong Wanzeng found that in the H0-SOP-61003-R01 disinfection solution configuration record (record number: 0000118) in the Y50-04 clean area related records, on October 20, 2019 The amount of ethanol added to the prepared 75% alcohol disinfectant is 1500ml, which is inconsistent with the 15L of ethanol usage record on the H3-SOP-61003-R01 workshop raw materials use account book (record number: 0001711) <br><br>The preparation staff Yao Xinyu was not careful when writing the record, mistakenly wrote 15000 as 1500, and the reviewer Xu Liya did not review carefully, resulting in deviations. <br><br>1. View the H3-SOP-61003-R01 workshop raw materials and auxiliary materials use account (record number: 0001711), the amount of ethanol used is 15L, view the H0-SOP-61003-R01 disinfectant configuration record (record number: 0000118) The volume of 75% alcohol is fixed to 20L, and after inquiring the personnel in the clean area, the personnel reported that when using the 75% alcohol disinfectant configured on 2019.10.20, the odor concentration of the disinfectant is the same as the previous configuration, so 75% alcohol The concentration is correct to meet the disinfection requirements. 2. Since the Y50-04 clean area has been put into use, doxorubicin and epirubicin have not undergone deviations due to incomplete disinfection of the product microorganisms, so this deviation has no effect on product quality. <br><br>1. Correctly modify the ethanol dosage of the 75% alcohol disinfectant solution prepared on 2019.10.20 in the H0-SOP-61003-R01 disinfectant configuration record (record number: 0000118). <br>2. Train the relevant personnel in the H0-SOP-01002 "GMP Original Records Management Procedure" version 05 training, requiring personnel to be careful when writing records to ensure that the records are true, accurate and complete.

At 15:33, 2019.10.23, Tong Wansheng, when checking the relevant records of the Y50-04 clean area, found that in the H0-SOP-61003-R01 disinfection liquid configuration record (record number: 0000118), the amount of 75% alcohol disinfection liquid added ethanol on 2019.10.20 was 10ml. It is inconsistent with the ethanol usage record 15L on the raw material usage ledger (record book no. 0001711) on the H3-SOP-61003-R01 workshop. <br><br>Preparation personnel Yao Xinyu did not write the record carefully, miswriting 15000 as 1500, and the reviewer Xu Lia review is not careful, resulting in deviation. <br><br>1. View H3-SOP-61003-R01 Workshop Raw Materials Use Ledger (Record No.: 0001711), Ethanol Use 15L, View H0-SOP-61003-R01 Disinfector configuration record (record code: 0000118), 75% alcohol fixed to 20L, and after questioning the clean area personnel, personnel feedback in the use of the 2019.10.20 configuration of 75% of alcohol disinfectant, Its disinfection liquid odor concentration is the same as previously configured, so 75% of the alcohol concentration is correct, to meet the disinfection requirements. 2.Y50-04 clean area since the use of the star and table soft star did not occur due to disinfection is not completely lead to the product microbial non-conforming deviation, so this deviation has no effect on product quality. <br><br>1. Correctly modify the ethanol addition of 75% alcohol disinfectant formulated on the 2019.10.20 in h0-SOP-61003-R01 disinfection liquid configuration record (record book no. 0000118).<br>2. The relevant personnel h0-SOP-01002 "GMP original record management procedures" 05 version of the training, requiring personnel to write records carefully, to ensure that the records are true, accurate and complete.

At 15:33 on October 23, 2019, Tong Wanzeng found that in the h0-sop-61003-r01 disinfectant configuration record (record book No.: 0000118), the amount of ethanol added to 75% alcohol disinfectant prepared on October 20, 2019 was 1500ml, which was in line with the amount of ethanol used in h3-sop-61003-r01 workshop raw and auxiliary materials use account (record book No.: 0001711) Record 15L is inconsistent.<br>Yao Xinyu, the compounder, did not carefully write the record, mistakenly wrote 15000 into 1500, and Xu Liya, the reviewer, did not carefully review it, resulting in deviation.<br>1. Check h3-sop-61003-r01 workshop raw and auxiliary materials use account (record book No.: 0001711), ethanol use amount is 15L, check h0-sop-61003-r01 disinfectant configuration record (record book No.: 0000118), 75% alcohol constant volume to 20L, and after asking the clean area personnel, the personnel feedback when using 75% alcohol disinfectant configured on October 20, 2019, the odor concentration of disinfectant and the previous configuration It is the same, so 75% alcohol concentration is correct, meeting the disinfection requirements. 2. Since y50-04 clean area was put into use, doxorubicin and superfine doxorubicin did not lead to the deviation of unqualified product microorganism due to incomplete disinfection, so this deviation has no impact on product quality.<br>1. Correct the ethanol dosage of 75% alcohol disinfectant prepared on October 20, 2019 in h0-sop-61003-r01 disinfectant configuration record (record book No.: 0000118).<br>2. Train the relevant personnel in version 05 of GMP original record management procedure (h0-sop-01002). The personnel are required to write the records carefully to ensure the authenticity, accuracy and integrity of the records.