1.在CCMM1715中，对左氧氟沙星半水合物工艺及质量标准变更评估不

1. In CCMM1715, the levofloxacin hemihydrate technology and quality standards is not sufficient to assess changes, in January 2019 we conducted a risk assessment of the changes, use the API after the change revalidation process is carried out to further evaluate the finished product affect quality. <br>2. WHO official requirements for levofloxacin tablets USP, 500mg information in an increase in the score, only in the product registration process documents in the report were to describe the appearance of the production and revision of relevant research and small scale score sheet, but in 307 workshop conduct research on the production and scored tablets breaking scored tablets of the QC laboratory. "

1. In CCMM1715, the change of the left oxyfluoroxaxax aminepand ahalfor process and quality standard was not fully evaluated, and the change was carried out in January 2019, and the process re-validation needed to be carried out using the changed API to further assess the impact on the quality of the finished product.<br>2. For WHO official requirements left oxyfluora star tablet Sp, 500mg increase in the incarcek information, only in the product registration reporting process document for the appearance description was revised and small test indentation tablet production and related research, but not in the 307 workshop of the production of the engraving tablets and QC laboratory after the inscription sliver of the relevant research. "

1. In ccmm1715, the assessment of the change of process and quality standard of levofloxacin hemihydrate was insufficient. In January 2019, the risk assessment of the change was carried out, and the process revalidation of the changed API was needed to further assess the impact on the quality of the finished product.<br>2. For the information that who requires levofloxacin tablet USP, 500mg to add middle scoring, only the appearance description was revised in the product registration and reporting process document, as well as the production and related research of small-scale test scoring tablet, but the production of scoring tablet and the related research after the chip breaking by QC laboratory were not carried out in workshop 307. "