2019年07月17日08时26分，西司他丁钠冻干生产主管张溟在D30

At 08:26 on July 17, 2019, Zhang Ming, director of freeze-dried production of cilastatin sodium, found the eighth step of the 2017-190703 batch of freeze-dried cilastatin sodium on the main interface of D3003A freeze dryer (-5 ℃, 0.28mbar, 9h) is inconsistent with the eighth step of the process requirements (-5 ℃, 0.28mbar, 15h). <br><br>After the modification of the eighth step of the freeze dryer, it was not changed back in time, which was the direct cause of the deviation. Neither the operator nor the reviewer carefully checked the freeze-drying process. The root cause. <br><br>The key process of the 2017-190703 batch of cilastatin sodium freeze-drying process is inconsistent with the cilastatin sodium process specification, so it is destroyed according to unqualified products. <br>After the 2017-190703 batch of cilastatin sodium lyophilization process was completed, the eighth step of the process (-5 ℃, 0.28mbar, 9h) was changed back to the eighth step (-5 ℃, 0.28mbar, 15h), so No effect on the quality of the next batch of products. <br><br>1. Change the eighth step of the process (-5 ℃, 0.28mbar, 9h) back to the eighth step (-5 ℃, 0.28mbar) after the 2017-190703 batch of cilastatin sodium freeze-drying process is completed and before the next batch of production , 15h). <br>2. Train the personnel in the freeze-drying post on the "H3-MPD-10318-15 Sterile Cisterastine Sodium Freeze-drying Post Operation Procedure (Y76E)" training, emphasizing that the freeze-drying process is started, and the freeze-drying process parameters must be carefully checked.

On July 17, 2019, at 08:26, Zhang Wei, head of sodium freeze-dried production, viewed the 2017-190703 batch on the main interface of the D3003A freeze-drying machine computer. When the sodium sodium freeze-drying procedure of sistadine was found to be inconsistent with the eighth step (-5c, 0.28mbar, 9h) and the eighth step of the process requirement (-5C, 0.28mbar, 15h). <br><br>After the eighth step of the freeze-drying machine procedure was modified, it was not changed back in time, which was the direct cause of the deviation, and neither the operator nor the reviewer carefully checked the freeze-drying process, so that no abnormality was found in the freeze-drying process, which is the root cause of the deviation.<br><br>2017-190703 batch of sittatin sodium freeze-dried process production of the key process and sistatin sodium process procedures are not consistent, so according to non-conforming products for destruction treatment.<br>After the production of the 2017-190703 batch of satadine sodium freeze-dried process, the eighth step of the process (-5 degrees C, 0.28 mbar, 9h) has been changed back to the eighth step (-5 degrees C, 0.28 mbar, 15h), so it has no effect on the quality of the next batch of products.<br><br>1. Change the eighth step of the process (-5 degrees C, 0.28 mbar, 9h) to step 8 (-5 degrees C, 0.28 mbar, 15h) after the production of the 2017-190703 batch of sistatin sodium freeze-drying process and before the next batch of production.<br>2. To freeze-dried staff "H3-MPD-10318-15 sterile sitatria sodium freeze-dried post operating procedures (Y76E)" training, emphasizing the opening of freeze-dried process, to carefully check the freeze-drying process parameters.

At 08:26 on July 17, 2019, when Zhang Ming, the production director of cilastatin sodium freeze drying, checked the 2017-190703 batch of cilastatin sodium freeze drying program on the main computer interface of d3003a freeze dryer, he found that the eighth step (- 5 ℃, 0.28mbar, 9h) was inconsistent with the eighth step (- 5 ℃, 0.28mbar, 15h) required by the process.<br>After the eighth procedure of the lyophilizer was modified, it was not changed back in time, which was the direct cause of the deviation, while the operators and reviewers did not carefully check the lyophilization process, so no abnormality was found in the lyophilization process, which was the root cause of the deviation.<br>The key process of 2017-190703 batch of cilastatin sodium freeze-drying process is inconsistent with the process specification of cilastatin sodium, so the unqualified products are destroyed.<br>After the production of 2017-190703 batch of cilastatin sodium freeze-drying process, the eighth step (- 5 ℃, 0.28mbar, 9h) of the process has been changed back to the eighth step (- 5 ℃, 0.28mbar, 15h), so there is no impact on the quality of the next batch of products.<br>1. Change the eighth step (- 5 ℃, 0.28mbar, 9h) back to the eighth step (- 5 ℃, 0.28mbar, 15h) after the completion of 2017-190703 batch of cilastatin sodium freeze-drying process and before the next batch of production.<br>2. Carry out "h3-mpd-10318-15 aseptic cilastatin sodium freeze-drying post operation procedure (y76e)" training for freeze-drying post personnel, emphasize to start the freeze-drying process, and carefully check the freeze-drying process parameters.<br>