受台风“利奇马”影响，岩头厂区部分电气设备发生跳闸停电。2019.08

Affected by typhoon "Lichma", some electrical equipment in the Yantou factory area tripped and blacked out. 2019.08.10 00:38 flash, 00:43 power outage, 00:52 power transmission. <br><br>This deviation is mainly caused by a strong typhoon, is a force majeure factor, and is an environmental cause. <br><br>1. The deviation has no effect on the product quality of the oncology department, but the plant needs to be maintained. For details, please refer to the "Deviation Investigation-Annex 09: Anti-tumor Department Lichma Typhoon Impact Assessment Form". 2. Except for cilastatin sodium 2017-190802 treated as unqualified products, this deviation has no effect on the quality of other products of the synthesis division. For details, please refer to "Deviation Investigation-Annex 10: Typhoon Lichma of the Aseptic Group of the Synthesis Division Impact Assessment Form "and" Deviation Survey-Annex 11: Synthetic Division Non-sterile Group Typhoon Lichma Impact Assessment Form ". 3. The affected workshop needs to be maintained. Except for mevastatin (3025-A190712) and teicoplanin (2121-190701), the deviation has no effect on the quality of other products of Weiyi Division. See "Deviation Survey-Annex 12: Microbiology First Division Lichma Typhoon Impact Assessment Form". 4. The deviation has no effect on the product quality of Micro Division II, but the plant needs to be maintained. For details, please refer to "Differential Survey-Annex 13: Microbiology Division II Lichma Typhoon Impact Assessment Form". 4. Neither the API warehouse nor the public water and gas systems have been affected by the typhoon. For details, please refer to the "Deviation Survey-Annex 14: API QC Lichma Typhoon Impact Assessment Form"<br><br>1. Maintain the north middle gate beam on the first floor of Y20 building. 2. Maintain the manhole on the top third floor of Y20 building. 3. Repair the southeast roof of the first floor of Y33 building. 4. Maintain the east, south and north walls of the fourth floor of Y33 building. 5. Repair the outer wall metal sheet on the east, south and north sides of the third floor of the Y36 building. 6. Repair the southwest corner windows of the third floor of Y36 building. 7. Repair the ceiling of the Y36 men's locker room. 8. Repair the Y36 building FU5-1 exhaust fan group. 9. Repair the outer skin of the south wall of the third floor of the Y37 building. 10. Repair Y37 building FU6-1 exhaust fan group. 11. Repair the southeast corner windows of the third floor of Y37 building. 12. Repair the glass door of Y38 water pump area. 13. Repair the fire door on the top of the Y38 building. 14. Maintain the north middle gate beam on the first floor of Building Y39. 15. Repair the windows of No.1 and No.9 operating rooms of Y39 building. 16. Repair the escape gate of the southeast corner of Y39 building. 17. Repair the glass door on the top of Y50 building. 18. Maintain the aisle and wall on the second floor of the Y50 sterile general production area. 19. Repair the south wall of Y50 building. 20. Repair the blinds of the room on the fourth floor of the Y50 air-conditioning unit. 21-27 CAPA in the penultimate row of this form (row 999)

Affected by Typhoon Lichma, some electrical equipment in the Iwate plant tripped and lost power. 2019.08.10 00:38 flash speed, 00:43 power outage, 00:52 power transmission. <br><br>This deviation is mainly caused by super typhoon, is an irresistible factor, belongs to environmental reasons. <br><br>1. The deviation against the quality of the oncology division has no effect, but the plant needs to be maintained, see "Deviation Investigation - Annex 09: Anti-Oncology Division Lichma Typhoon Impact Assessment Form." 2. In addition to the treatment of sodium satibutin222017-190802 according to non-conforming products, the deviation has no effect on the quality of other products in the synthesis division, as detailed in the "Deviation Investigation - Annex 10: Aseptic Group Ofe Typhoon Impact Assessment Form" and "Deviation Investigation - Annex 11: Non-sterile Group Lichma Typhoon Impact Assessment Table" of the Synthesis Division. 3. The affected plant needs maintenance, in addition to mevastatin (3025-A190712), for koalaning (2121-190701) to track the quality of the finished product, the deviation on the quality of other products of the micro-business unit has no effect, see "deviation investigation - Annex 12: micro-organisms first division of the Lichma Typhoon impact assessment table." 4. The deviation has no effect on the product quality of the micro-second business unit, but the plant needs to be maintained, as detailed in the "Deviation Investigation - Annex 13: Micro-Organisms Second Division Of Lichma Typhoon Impact Assessment Form". 4. API warehouse and public water and gas systems were not affected by typhoons, as detailed in "Deviation Survey - Annex 14: API QC Lichma Typhoon Impact Assessment Form"<br><br>1. Maintenance of the North Middle Door Beam slabs of Y20 buildings on the first floor. 2. Maintenance of the y20 East Third Roof Manhole. 3. Repair of the south-east roof of Y33, a first-floor building. 4. Maintenance of the east, south and north walls of Y33 buildings on the fourth floor. 5. Repair of the iron of the exterior walls of Y36 buildings on the east, south and north of the third floor. 6. Repair the windows of the south-west corner of the Y36 building on the third floor. 7. Repair of the ceiling of the Y36 men's locker room. 8. Repair of Y36 FU5-1 exhaust units. 9. Repair of the iron on the south facade of Y37 buildings on the third floor. 10. Repair of The Y37 FU6-1 exhaust units. 11. Repairs were made to the south-east corner windows of Y37 buildings on the third floor. 12. Repair of glass doors in the Y38 water pump area. 13. Fire doors on the roofs of Y38 buildings were repaired. 14. Maintenance of the North Middle Gate Beams of Y39 on the first floor. 15. Repairs were made to the windows of operating rooms 1 and 9 of Y39. 16. Repairs were made to the Y39 South-East Corner Escape Gate. 17. Repair of the roof glass doors of the Y50 building. 18. Maintenance of the second floor walkways and walls of Y50 aseptic fission common production area. 19. Repair of the Y50 south facade. 20. The shutters of the room of the Y50 four-story table-table Jubi star air-conditioned unit were repaired. 21-27 CAPA in the penultimate row of this table (line 999)

Affected by Typhoon "lichima", part of the electrical equipment in Yantou plant area was tripped and cut off. August 10, 2019: 00:38 flash, 00:43 power failure, 00:52 power transmission.<br>This deviation is mainly caused by super typhoon, which is an irresistible factor and belongs to environmental reason.<br>1. The deviation has no impact on the product quality of the cancer business unit, but the plant needs to be maintained. See "deviation survey annex 09: impact assessment form of typhoon lichima of the cancer business unit" for details. 2. Except that cilastatin sodium 2017-190802 is treated as unqualified product, the deviation has no impact on the quality of other products of the synthesis business unit. For details, please refer to "deviation survey annex 10: evaluation form of leechmatai wind impact of the sterile group of the synthesis business unit" and "deviation survey annex 11: evaluation form of leechmatai wind impact of the non sterile group of the synthesis business unit". 3. The affected plant needs to be maintained. Except that Mevastatin (3025-a190712) and teicoplanin (2121-190701) need to track the quality of the finished products, the deviation has no impact on the quality of other products of the micro-1 business unit. For details, please refer to "deviation survey annex 12: assessment form of leechmatai wind impact of the first microbial business unit". 4. The deviation has no impact on the product quality of the micro second business unit, but the plant needs to be maintained. For details, please refer to "deviation survey annex 13: impact assessment form of typhoon lichima of the micro second business unit". 4. API warehouse, public water and gas system are not affected by typhoon. See "deviation survey annex 14: API QC typhoon impact assessment form" for details<br>1. Maintain the north middle door beam of the first floor of building Y20. 2. Maintain manhole on the top of the third building in the east of building Y20. 3. Repair the southeast roof of the first floor of building y33. 4. Maintain the East, South and North walls of building y33. 5. Repair the outer wall iron sheet on the East, South and north of the third floor of building y36. 6. Repair the window at the southwest corner of the third floor of building y36. 7. Repair the ceiling of the men's changing room in building y36. 8. Repair fu5-1 exhaust unit of y36 building. 9. Repair the outer wall iron sheet on the south of the third floor of building y37. 10. Repair fu6-1 exhaust unit of y37 building. 11. Repair the southeast corner window of building y37. 12. Repair the glass door in the water flushing pump area of building Y38. 13. Repair the fire door on the roof of building Y38. 14. Maintain the north middle door beam of the first floor of building y39. 15. Repair the windows of No.1 and No.9 operation rooms in building y39. 16. Repair the escape door at the southeast corner of building y39. 17. Repair the glass door on the roof of building Y50. 18. Maintain the walkway and wall on the second floor of general production area of aseptic silk crack in building Y50. 19. Repair the South exterior wall of building Y50. 20. Repair the louvers in the room of the air conditioning unit on the fourth floor of building Y50. 21-27 CAPA in the second to last line of this table (line 999)<br>