1 Replace sealing ring and recombine RO membrane 2 replace RO membrane 3 Regular pasteurization 4 RO produced water conductivity has online monitoring and alarm functions. The quality of purified water does not meet the pharmacopoeia standard. Heat exchanger failure Unit sensor failure Respirator damage Valve failure Circulating pump failure Improper process parameters or defects in daily maintenance Dosing pump fault 1. In the performance confirmation of purified water system, confirm the key operating parameters of the system. 2. Record the key operation parameters every 2h. 3. Make sure the components are in good condition. 4. Strengthen the daily maintenance of the system. 5. Calibrate relevant instruments periodically. System alarm fault Alarm component failure 1. In the performance confirmation of purified water system, confirm the key operating parameters of the system. 2. Make sure the components are in good condition 3. Strengthen the daily maintenance of the system 4. Check related instruments periodically. The water quality of newly added purified water systems PW 906 PW 907 and PW 908 does not meet the production standards. The new equipment has not been tested by periodic sampling. PW 906, PW 907 and PW 908 will go through two cycles of intensive sampling before they are put into production, and will be put into production after two cycles of sampling are qualified. See Annex 1 for details. Purified water system PW908 backwater flow is low. The water consumption at the point of use of V0421 increased. 1. The backwater flow alarm function is set in the distribution system. 2. When the backwater flow gives an alarm, pay attention to the backwater flow and coordinate the workshop water use when necessary. 3. Confirm the backwater flow during the verification period. Purified water system The raw water quality of pretreatment system is poor, which affects the system capacity. The raw water is surface reservoir water, and the water quality is greatly affected by seasons. QC samples regularly to ensure that the water quality meets the drinking standard. The second workshop of recombinant human insulin injection Scheme and report on performance reconfirmation of purified water system Document number: DY-PPQ009E Version number: 00 PAGE 18, NUMPAGES 55 in total It is forbidden to copy confidential documents without permission. GMP range This scheme covers the performance reconfirmation of purified water system. This PQ scheme completes the confirmation of CQA and CPP recognized by the system. The following table includes CQA and its related CPP, and mentions the test items involved in this scheme. The first table includes CQA of purified water system, and the second table includes CPP of purified water system. PW- purified water system CQA key quality attributes Test strategy Test item CQA1: Conductivity

1 Replace sealing ring and recombine RO membrane 2 replace RO membrane 3 Regular pasteurization 4 RO produced water conductivity has online monitoring and alarm functions. The quality of purified water does not meet the pharmacopoeia standard. Heat exchanger failure Unit sensor failure Respirator damage Valve failure Circulating pump failure Improper process parameters or defects in daily maintenance Dosing pump fault 1. In the performance confirmation of purified water system, confirm the key operating parameters of the system. 2. Record the key operation parameters every 2h. 3. Make sure the components are in good condition. 4. Strengthen the daily maintenance of the system. 5. Calibrate relevant instruments periodically. System alarm fault Alarm component failure 1. In the performance confirmation of purified water system, confirm the key operating parameters of the system. 2. Make sure the components are in good condition 3. Strengthen the daily maintenance of the system 4. Check related instruments periodically. The water quality of newly added purified water systems PW 906 PW 907 and PW 908 does not meet the production standards. The new equipment has not been tested by periodic sampling. PW 906, PW 907 and PW 908 will go through two cycles of intensive sampling before they are put into production, and will be put into production after two cycles of sampling are qualified. See Annex 1 for details. Purified water system PW908 backwater flow is low. The water consumption at the point of use of V0421 increased. 1. The backwater flow alarm function is set in the distribution system. 2. When the backwater flow gives an alarm, pay attention to the backwater flow and coordinate the workshop water use when necessary. 3. Confirm the backwater flow during the verification period. Purified water system The raw water quality of pretreatment system is poor, which affects the system capacity. The raw water is surface reservoir water, and the water quality is greatly affected by seasons. QC samples regularly to ensure that the water quality meets the drinking standard. The second workshop of recombinant human insulin injection Scheme and report on performance reconfirmation of purified water system Document number: DY-PPQ009E Version number: 00 PAGE 18, NUMPAGES 55 in total It is forbidden to copy confidential documents without permission. GMP range This scheme covers the performance reconfirmation of purified water system. This PQ scheme completes the confirmation of CQA and CPP recognized by the system. The following table includes CQA and its related CPP, and mentions the test items involved in this scheme. The first table includes CQA of purified water system, and the second table includes CPP of purified water system. PW- purified water system CQA key quality attributes Test strategy Test item CQA1: Conductivity