瑞舒伐他汀钙片的原料药工艺和设备变更：1. 设备变更：1) 瑞舒伐他汀

Rosuvastatin calcium of drug and device change process: <br>1. Change the device: <br>1) rosuvastatin calcium 5mg new P3030 tabletting step tableting machine (device number: 121302-307-0003), and tabletting step for cleaning validation. <br>2) 5mg of rosuvastatin calcium (Packing: new plastic packaging line 2 7 / plate / cartridge and 7/2 plate * plate / box) packaging process. <br>3) rosuvastatin calcium tablets 10mg & 20mg remain unchanged. <br>2. Process Change: <br>rosuvastatin calcium 5mg & 10mg oven granulating step was changed from the amount of intake air damper 3500m3 / h of 3500-4500m3 / h, while increasing the drying process stacker operation, and rosuvastatin calcium consistent 20mg . <br>3. After this change the internal plan is approved, the use of raw materials after the change were rosuvastatin calcium 5mg & 10mg & 20mg three sizes each process validation batches of 3, and drafted the corresponding file validation and batch recording. <br>4. 9 batch validation batches for long-term and accelerated stability studies. "

Changes in API processes and equipment for reschofatin calcium tablets:<br>1. Equipment changes:<br>1) Reschoffattin 5mg tablet 5mg tablet process new P3030 tablet press (device number: 121302-307-0003), and the tablet process for cleaning verification.<br>2) Reschoffattin calcium tablets 5mg (packaging specifications: 7 pieces / plate / box and 7 pieces / plates / 2 boards / boxes) packaging process added aluminum plastic packaging line 2.<br>3) Reschoffattin calcium tablets 10mg and 20mg remain unchanged.<br>2. Process changes:<br>The air wind volume of the oven of the reshubatin calcium tablets 5mg and 10mg granulatin is changed from 3500m3/h to 3500-4500m3/h, while the flip operation is increased during the drying process, consistent with the 20mg of the calcium tablets of Reschoffattin.<br>3. After the internal approval of this change, the process verification of 3 batches of three specifications of Rissovastatin calcium tablets of 5mg and 10mg and 20mg is carried out using the changed raw materials, and the corresponding verification documents and batch records are drafted.<br>4. Conduct long-term and accelerated stability studies on 9 batch of validated batch products. "

Change of API process and equipment of rosuvastatin calcium tablets:<br>1. Equipment change:<br>1) P3030 tablet press (equipment No.: 121302-307-0003) was added in the 5mg tablet pressing process of rosuvastatin calcium tablet, and the tablet pressing process was cleaned and verified.<br>2) 5 mg of rosuvastatin calcium tablets (package specification: 7 pieces / plate / box and 7 pieces / plate * 2 plates / box) new aluminum plastic packaging line 2 was added in the packaging process.<br>3) Rosuvastatin calcium tablets 10mg-20mg remained unchanged.<br>2. Process change:<br>The air volume of drying oven in the granulation process of 5 mg-10 mg of rosuvastatin calcium tablet changed from 3500m3 / h to 3500-4500m3 / h, and the operation of turning over was added in the drying process, which was consistent with that of 20 mg of rosuvastatin calcium tablet.<br>3. It is planned that after the internal approval of the change, three batches of process validation of risuvastatin calcium tablets of 5mg-10mg-20mg in three specifications will be carried out with the changed raw materials, and corresponding validation documents and batch records will be drafted.<br>4. Carry out long-term and accelerated stability study on 9 batches of validation products. "<br>