该偏差为设备原因引起，对岩头厂区抗肿瘤事业部IPC实验室博来霉素和伊达

This deviation was caused by equipment, which affected the detection of bleomycin and idarubicin in the IPC laboratory of the Anti-tumor Division of Yantou Plant. After reanalysis, the test results were in compliance with the requirements and had no impact on the test results; this deviation As a result, the sterility of the 2087021N210504 batch of meropenem and the 2017011N210503 batch of cilastatin sodium in the aseptic workshop of the Synthetic Division cannot be guaranteed, and destruction is planned; the Y76E air-conditioning system is shut down, and the Y73 air-conditioning system is shut down, which may affect the sterility of the product. Impact, the two clean areas have been re-sterilized, and there is no impact on subsequent products. In addition to the above, the deviation has little impact on the warehouse, IPC laboratory, product and workshop material quality, air-conditioning system, and public systems (power workshop, water system) in the Yantou plant area, and the risk is controllable. At the same time, in order to reduce the risk, plan Replace 1# main transformer switch breaker.

The deviation was caused by the equipment, which affected the detection of bleomycin and idarubicin in IPC Laboratory of anti-tumor division of Yantou factory. After re analysis, the detection results met the requirements, and had no impact on the test results; As a result, the sterility of meropenem 2087021n210504 batch and cilastatin sodium 2017011n21003 batch in the sterile workshop of Synthesis Division could not be guaranteed, so it was planned to destroy them; The shutdown of y76e air conditioning system and Y73 air conditioning system may affect the sterility of the products. The two clean areas have been re disinfected, and there is no impact on the subsequent products. In addition, the deviation has a small impact on the warehouse, IPC laboratory, product and workshop material quality, air conditioning system and public system (power workshop and water system) in Yantou plant, and the risk is controllable. In order to reduce the risk, it is planned to replace the 1 # main transformer switch breaker.<br>

This deviation is caused by equipment, which affects the detection of bleomycin and idarubicin in IPC laboratory of anti-tumor division of Yantou factory. After re-analysis, the detection results meet the requirements and have no impact on the detection results; Due to this deviation, the sterility of meropenem 2087021N210504 batches and cilastatin sodium 2017011N210503 batches in the aseptic workshop of Synthetic Division cannot be guaranteed, so it is planned to destroy them. The shutdown of Y76E air-conditioning system and Y73 air-conditioning system may have an impact on the sterility of products. These two clean areas have been re-disinfected, which has no impact on the subsequent products. In addition to the above, the deviation has little impact on the warehouse, IPC laboratory, product and workshop material quality, air conditioning system and public system (power workshop and water system) in Yantou Plant, and the risk is controllable. In order to reduce the risk, it is planned to replace the switch breaker of No.1 main transformer.