甲氨蝶呤片引入309车间5楼片剂生产线的变更（后续处理）：1.增加 “

Methotrexate sheet changes are introduced (subsequent process) 309 5 workshop floor tablet production line: <br>1. Add "to complete the feasibility of subsequent batches of sheet production methotrexate, and complete the feasibility of cleaning validation report and batch report "of the measure. <br>2. Change action items "Methotrexate tablets drafting process validation scheme, cleaning validation program, batch records and process planning and training" postponed to 2019.12.31. <br>3. Change action items "to complete the process validation and cleaning validation report Report" postponed to 2020.04.30. "

Changes to the tablet production line for the introduction of methotrexate tablets on the 5th floor of the 309 workshop (follow-up):<br>1. Increase the "complete the production of the subsequent feasibility batch of methotrexate tablets, and complete the corresponding cleaning confirmation report and feasibility batch report" this measure.<br>2. Postpone the change measure item "Draftmethotrextablet process verification program, cleaning verification program, process procedure and approval record and training" to 2019.12.31.<br>3. Extend the change measure item "Complete Process Verification Report and Cleaning Verification Report" to 2020.04.30. "

Change of tablet production line on floor 5 of workshop 309 for the introduction of Methotrexate Tablets (follow-up treatment):<br>1. Add the measure of "complete the production of subsequent feasible batches of methotrexate tablets, and complete the corresponding cleaning confirmation report and feasibility Batch Report".<br>2. Postpone the change measure item "drafting the methotrexate process validation plan, cleaning validation plan, process procedures, batch records and training" to December 31, 2019.<br>3. Postpone the change measure item "completion of process validation report and cleaning validation report" to April 30, 2020. "<br>