Because methotrexate tablets the first feasibility batch production process part of the process content and content uniformity test results can not reach the target of the target of the target of the target quality standards, so a batch of feasibility batch of materialation for further research. In the second feasibility batch production process, the production line used equipment chip press failure, tablet processing and subsequent operations can not be completed, can not export the key process parameters to guide the validation batch production, resulting in the subsequent methotrexate tablet verification batch document drafting and production work delayed, can not be completed in accordance with the original plan, Therefore, the follow-up related action measures need to be extended.
正在翻译中..