1）设备设计、选型、维护内容及周期不合理，不便于操作、清洁、维护；没有

1) The equipment design, selection, maintenance content and cycle are unreasonable, which is not easy to operate, clean and maintain; no necessary disinfection or sterilization is carried out. <br><br><br><br><br>1) "CL-POL-FE001 GMP plant facility design review" stipulates: the design or selection of equipment should meet the requirements of pharmaceutical production and technology, safe, stable, reliable, easy to clean, disinfect or sterilize, and facilitate production operation and maintenance Maintenance, and can prevent personnel errors and cross-contamination. <br>2) The "H0-SOP-20074 Equipment Use and Maintenance Management Procedures" stipulates: <br>--- Preventive maintenance of equipment should be carried out regularly and the maintenance content and cycle should be specified in the use and maintenance procedures. The maintenance cycle is generally daily, monthly, quarterly, annual It can also be set up according to the actual situation every week, every six months, every two years and other different periods of maintenance. <br>--- Routine maintenance mainly inspects, cleans and wipes the equipment to keep the equipment in a tidy, clean, safe and well-lubricated state. The daily maintenance cycle should be clearly defined as every shift, daily or weekly. <br>Conclusion: The existing SOP meets regulatory requirements.

1）设备设计、选型、维护内容及周期不合理，不便于操作、清洁、维护；没有进行必要的消毒或灭菌。<br><br><br><br><br>1）“CL-POL-FE001 GMP厂房设施设计审核”规定：设备的设计或选型应符合药品生产及工艺的要求，安全、稳定、可靠、易于清洗、消毒或灭菌，便于生产操作和维修保养，并能防止人员差错和交叉污染。<br>2）“H0-SOP-20074 设备使用维护管理程序” 规定：<br>---应定期对设备进行预防性维护并在使用维护规程中规定维护内容及周期，维护周期一般为日常、月度、季度、年度，也可根据实际情况制定每周、每半年、每两年等不同周期的维护。<br>---日常维护主要对设备的检查、清扫和擦拭，使设备处于整齐、清洁、安全、润滑良好的状态，应明确日常维护周期为每班、每天或每周。<br>结论：现有SOP符合法规要求。

1) The equipment design, type selection, maintenance content and cycle are unreasonable, which is not convenient for operation, cleaning and maintenance; there is no necessary disinfection or sterilization.<br>1) "Cl-pol-fe001 GMP plant facility design review" stipulates that the design or type selection of equipment shall meet the requirements of drug production and process, be safe, stable, reliable, easy to clean, disinfect or sterilize, convenient for production operation and maintenance, and prevent personnel error and cross contamination.<br>2) "H0-sop-20074 equipment use and maintenance management procedure" stipulates:<br>---Preventive maintenance shall be carried out for the equipment on a regular basis and the maintenance content and cycle shall be specified in the use and maintenance procedures. The maintenance cycle is generally daily, monthly, quarterly and annual, and different maintenance cycles such as weekly, semi annual and biennial can also be formulated according to the actual situation.<br>---Daily maintenance is mainly to check, clean and wipe the equipment, so that the equipment is in a neat, clean, safe and well lubricated state. It should be clear that the daily maintenance cycle is every shift, every day or every week.<br>Conclusion: the existing SOP meets the requirements of the regulations.<br>