On October 23, 2019, at 15:33, Tong Wansheng, while verifying the relevant records of the Y50-04 clean area, found that 75% of the amount of alcohol-based alcohol ethanol added to ethanol in the H0-SOP-61003-R01 disinfection liquid configuration record (record number: 0000118) was 10ml10ml in the H0-SOP-6003-R01 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.
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