依据确认方案严格按计划去实施本次确认，确认方案在实施过程中未做修改，无

依据确认方案严格按计划去实施本次确认，确认方案在实施过程中未做修改，无偏差项，确认方案各项性能指标在确认过程中未做变动，所有工作均按标准操作规程和确认方案要求进行，确认结果IQ，PQ均符合要求，本过程确认符合要求，建议批准生效。<br>1.1 被确认对象的设备<br><br><br><br><br><br>1.2 再确认准则<br>1、 设备搬厂，以生产地区域地点转移为准,设备的楼层挪动以影响不影响工艺判定的结果为准，不影响则无需做，影响则需做，需要重新执行IQ；如果IQ显示无变化，则不需要执行OQ和PQ；<br>2、 设备大修或更换核心部件导致,需要重新执行IQ；如果IQ显示无变化，则不需要执行OQ和PQ；<br>3、 如果有新增的设备，则必须对新的设备执行IQ；如果新设备与原有设备无差异，则不需要执行0Q，但必须执行PQ;<br>4、 生产过程中质量不稳定可能影响产品质量时<br>5、 物料变更时，和已确认物料的复杂程度相比（参考物料选择描述的比较方法），如物料较复杂则需做再确认，执行OQ和PQ,但可以不执行IQ；<br>6、 参数变更、操作方式变更、接受准则变更时之一，需要重新再确认执行OQ和PQ；<br>7、 按照《迈瑞过程确认主计划》规定的周期性再确认时间进行再确认。<br>1.3 最佳参数表<br>干燥过程参数：

According to the confirmation plan, this confirmation was strictly carried out according to the plan. The confirmation plan was not modified during the implementation process, and there were no deviations. All performance indicators of the confirmation plan were not changed during the confirmation process. All work was carried out in accordance with the standard operating procedures and confirmation plan requirements, and the confirmation results IQ and PQ met the requirements. This process confirmation meets the requirements, and it is recommended to approve and take effect.<br>1.1 Equipment of the confirmed object<br>1.2 Reconfirmation criteria<br>1. Equipment relocation shall be based on the transfer of production areas and locations. The floor relocation of equipment shall be based on the results that do not affect the process judgment. If it does not affect, it is not necessary to do so. If it affects, it needs to be done, and IQ needs to be re executed; If there is no change in IQ display, there is no need to execute OQ and PQ;<br>2. Due to equipment overhaul or replacement of core components, IQ needs to be re executed; If there is no change in IQ display, there is no need to execute OQ and PQ;<br>3. If there are new devices, IQ must be performed on the new devices; If there is no difference between the new equipment and the original equipment, there is no need to execute 0Q, but PQ must be executed;<br>4. When unstable quality during the production process may affect product quality<br>5. When changing materials, compared to the complexity of the confirmed materials (refer to the comparison method described in the material selection description), if the materials are more complex, reconfirmation is required to execute OQ and PQ, but IQ may not be executed;<br>6. When changing parameters, operating methods, or acceptance criteria, it is necessary to reconfirm the execution of OQ and PQ;<br>7. Perform reconfirmation according to the periodic reconfirmation time specified in the "Mindray Process Confirmation Master Plan".<br>1.3 Best Parameter Table<br>Drying process parameters:

Carry out this confirmation strictly as planned according to the confirmation plan. The confirmation plan has not been modified and there are no deviations during the implementation. All performance indicators of the confirmation plan have not changed during the confirmation process. All work is carried out in accordance with the standard operating procedures and the requirements of the confirmation plan. The IQ and PQ of the confirmation results meet the requirements, and the confirmation of this process meets the requirements. It is recommended to approve and take effect.<br> 1.1 Equipment of the confirmed object<br> <br> <br> <br> <br> <br> 1.2 reconfirmation criteria<br> 1. The relocation of equipment shall be subject to the transfer of the location of the production area, and the floor relocation of equipment shall be subject to the result that the impact does not affect the process judgment. If it does not affect, it is not necessary to do it, and if it does, IQ needs to be re-implemented; If there is no change in IQ display, OQ and PQ do not need to be executed;<br> 2. IQ needs to be re-implemented due to equipment overhaul or replacement of core components; If there is no change in IQ display, OQ and PQ do not need to be executed;<br> 3. If there is new equipment, IQ must be performed on the new equipment; If there is no difference between the new equipment and the original equipment, it is not necessary to perform 0Q, but PQ must be performed;<br> 4. When the unstable quality in the production process may affect the product quality.<br> 5. When the material changes, compared with the complexity of the confirmed material (refer to the comparison method described in the material selection), if the material is complicated, it needs to be reconfirmed, and OQ and PQ are implemented, but IQ may not be implemented;<br> 6. In case of parameter change, operation mode change and acceptance criteria change, it is necessary to reconfirm the implementation of OQ and PQ;<br> 7. Re-confirm according to the periodic re-confirmation time specified in Mindray Process Confirmation Master Plan.<br> 1.3 the best parameter list<br> Drying process parameters: