1）纯化水、注射用水管道清洗消毒缺少记录，发现微生物污染达到警戒限度、

1) There is a lack of records in the cleaning and disinfection of purified water and injection water pipelines. When it is found that the microbial contamination reaches the warning limit and the correction limit, it is not handled according to the operating regulations. <br><br>"H0-SOP-20047 Purified Water System Operation and Maintenance Management Procedures" stipulates: each preparation system and distribution system of the purified water system must have an operation record. When recording data, you should first check the system for abnormal conditions such as alarms, and deal with them in time if necessary. <br>"H0-SOP-20048 water injection system operation and maintenance management procedures" stipulates: each injection water preparation system and distribution system should have an operation record. When recording data, you should first check the system for abnormal conditions such as alarms, and deal with them in time if necessary. <br>Conclusion: The existing SOP meets regulatory requirements.

1) Purified water, injection water pipe cleaning and disinfection lack of records, found that microbial pollution reached the alert limit, correction limit did not follow the operating procedures. <br><br>"H0-SOP-20047 Purified Water System Operation and Maintenance Management Procedure" stipulates that each preparation system and distribution system of the purified water system must have a track record of operation. When recording data, you should first check the system for alarm and other anomalies, if necessary to deal with in a timely manner.<br>The "H0-SOP-20048 Injection Water System Operation and Maintenance Management Procedure" stipulates that each injection water preparation system and distribution system should have a track record of operation. When recording data, you should first check the system for alarm and other anomalies, if necessary to deal with in a timely manner.<br>Conclusion: The existing SOP meets the regulatory requirements.

1) The cleaning and disinfection of purified water and injection water pipes are lack of records, and it is found that the microbial pollution is not handled according to the operating procedures when it reaches the warning limit and correction limit.<br>"H0-sop-20047 purified water system operation and maintenance management procedure" stipulates that each preparation system and distribution system of purified water system must have operation records. When recording data, check whether the system has abnormal conditions such as alarm first, and handle in time if necessary.<br>"H0-sop-20048 management procedure for operation and maintenance of WFI system" stipulates that each WFI preparation system and distribution system shall have operation records. When recording data, check whether the system has abnormal conditions such as alarm first, and handle in time if necessary.<br>Conclusion: the existing SOP meets the requirements of the regulations.<br>