难清洁设备或部件存在共用风险。1)“CL-POL-FE001 GMP厂

There is a risk of sharing equipment or components that are difficult to clean. <br><br><br>1) The "CL-POL-FE001 GMP plant facility design review" stipulates that: the design should consider the complexity of equipment and cleaning operations. For complex cleaning operations, automatic cleaning processes should be considered. Parts or equipment that are difficult to clean should be considered product specific. <br><br>2) "H3-SOP-41004 Production Equipment Cleaning Management Regulations" stipulates that equipment or components that are difficult to clean should be dedicated. Before the production of non-dedicated equipment is replaced, the equipment (especially the non-dedicated equipment starting from the refinement of crude products) must be thoroughly cleaned to prevent cross contamination. <br>Conclusion: The existing SOP meets regulatory requirements.

There is a common risk of difficult ymtoying equipment or components.<br><br>1) "CL-POL-FE001 GMP PLANT FACILITY DESIGN AUDIT" PROVISIONS: DESIGN TO CONSIDER THE COMPLEXITY OF EQUIPMENT AND CLEANING OPERATIONS, FOR COMPLEX CLEANING OPERATIONS, SHOULD CONSIDER THE USE OF AUTOMATIC CLEANING PROCESS. Parts or equipment that are difficult to clean should be considered for product use.<br><br>2) "H3-SOP-41004 Operating equipment cleaning management procedures" stipulates that difficult-to-clean equipment or components should be dedicated. Equipment (especially non-special equipment starting from crude refinement) must be thoroughly cleaned to prevent cross-contamination before the production of non-special equipment replacement varieties.<br>Conclusion: The existing SOP meets the regulatory requirements.

There is a common risk of difficult to clean equipment or components.<br>1) "Cl-pol-fe001 GMP plant facility design review" stipulates that the complexity of equipment and cleaning operation shall be considered in design, and for complex cleaning operation, automatic cleaning process shall be considered. Special products shall be considered for parts or equipment that are difficult to clean.<br>2) "H3-sop-41004 management procedure for cleaning of production equipment" stipulates that equipment or parts that are difficult to clean shall be used exclusively. Before changing varieties of non special equipment for production, it is necessary to thoroughly clean the equipment (especially the non special equipment starting from the crude refining) to prevent cross contamination.<br>Conclusion: the existing SOP meets the requirements of the regulations.<br>