故障发生在洁净区人流缓冲室的互锁门，造成无法互锁；洁净区的结晶釜减速机

The fault occurred in the interlocking door of the flow buffer room in the clean area, which caused it to be unable to interlock; <br>the crystallization kettle reducer in the <br>clean area leaked oil; the water pipe in the clean area of ​​the clean area leaked; the <br>transfer window UV lamp did not have a record of use, and the UV disinfection time and UV could not be traced Cumulative time of use of the lamp; <br>batch production record AFU50 (batch number: CN181202) in the process guide, the addition of hydrochloric acid takes 1-2 hours, but the actual dripping is completed in 29 minutes (P76). <br>No deviation records. <br>Audit conclusion

The fault occurs in the interlocking door of the clean area traffic buffer room, resulting in the inability to interlock;<br>The crystalline kettle reducer in the clean area is leaking oil;<br>Clean area cleaning pool under the water pipe leakage;<br>Transmission window UV lamp is not recorded, can not trace the UV disinfection time and the cumulative time of UV lamp use;<br>Batch production record AFU50 (lot number: CN181202) process guidance in the drip-adding hydrochloric acid takes 1-2 hours, but the actual 29 minutes to drip out (P76).<br>No deviation record.<br>Audit findings

The failure occurred in the airlock of the people flow buffer room in the clean area, which made it impossible to interlock;<br>The reducer of crystallizer in clean area leaks oil;<br>The water pipe of the cleaning pool in the clean area leaks;<br>There is no use record of the UV lamp in the delivery window, so it is impossible to trace the UV disinfection time and the cumulative use time of the UV lamp;<br>In the batch production record afu50 (batch No.: cn181202), it takes 1-2 hours to add hydrochloric acid in the process instruction, but the actual time is 29 minutes (P76).<br>No deviation record.<br>Audit conclusion<br>