2019年10月24日09：30，郑凯凯在Y52-01洁净区发现白色P

At 09:30 on October 24, 2019, Zheng Kaikai found that the opening date and expiration date on the remaining label of the white PE bag (batch number: B200026-190501Y) in the clean area of ​​Y52-01 did not match the registration with the ledger (number: 0002013). Fill in the opening date on the remaining labels as 2019.12.24, and the effective date as 2019.05.19, and register the PE bag issued on 2019.10.24, the effective date is 2021.05.19. <br><br>This deviation is mainly due to the operator's negligence and inattention, and incorrectly fill in the remaining label information of the white PE bag. <br><br>The B20026-190501Y batch of PE bags was released to the workshop after passing the QC test results. The quality of the white PE bag itself was qualified. The wrong label information will not affect the product quality. <br>The white PE bag was not used again after filling out the remaining label in employee Chen Jun. After finding that the remaining label information is wrong, the workshop has corrected the remaining label information in time and will not affect the subsequent use of the PE bag. <br>This deviation is the first deviation caused by Chen Junli's personal refining of rosuvastatin calcium. There is a certain chance that it will not affect the production of his participation. <br><br>1. Correct the label information of the white PE bag. <br>2. Train H0-SOP-01002 05 "GMP Original Record Management Procedures" for all employees in the rosuvastatin calcium position, emphasizing that the records should be accurate.

On October 24, 2019, at 09:30, Zheng Kaikai found in the Y52-01 clean area that the opening date and validity period on the remaining label of the white PE bag (lot number B200026-190501Y) did not match the registration of the account (No. 0002013). The remaining label on the opening date is filled in for 2019.12.24, the valid date is filled in for 2019.05.19, the ACCOUNT registration of the PE bag 2019.10.24 issued, the effective date is 2021.05.19. <br><br>This deviation is mainly due to the operation of the staff due to personal negligence, inattention, the remaining label information of the white PE bag filled in the error. <br><br>The B20026-190501Y batch PE bag by QC test results qualified before released to the workshop, white PE bag itself quality qualified, label information error will not affect product quality. <br>The white PE bag since the employee Chen Jun filled in the remaining label, not used again, found that the remaining label information error, the workshop has promptly corrected the remaining label information, will not affect the next PE bag use.<br>This deviation is Chen Junli personally in the Ruishuvastatin calcium refining post for the first time caused by the deviation, there is a certain degree of chance, will not have an impact on the production involved in it.<br><br>1. Correct the white PE bag label information.<br>2. All employees in the Shhuvastatin calcium position were trained in H0-SOP-01002 05 GMP Original Records Management Procedure, emphasizing that the records should be accurate.

two thousand and nineteen year Ten month Twenty-four day 09 : Thirty , Zheng Kaikai Y52-01 White in clean area PE Bag (batch No.: B200026-190501Y ）Opening date, validity and account of the remaining labels (No.: 0002013 ）Registration does not match. The opening date of the remaining labels shall be filled in as 2019.12.24 , valid on 2019.05.19 , the account registers the PE bag 2019.10.24 Issued effective on 2021.05.19 。<br>This deviation is mainly due to the operator's personal negligence and inattention, which makes the PE The remaining label information of the bag is filled in incorrectly.<br>The B20026-190501Y batch PE Bag meridian QC Only after the test result is qualified can it be released to the workshop, white PE The quality of the bag itself is qualified, and the wrong label information will not affect the product quality.<br>This white PE The bag has not been used again since Chen Junli, an employee, filled in the remaining label. After finding the error of the remaining label information, the workshop has corrected the remaining label information in time and will not connect it PE Bag use has an impact.<br>This deviation is the first one caused by Chen Junli in the refining post of rosuvastatin calcium. It has certain contingency and will not affect the production he participates in.<br>One Right white PE Bag label information to be corrected.<br>Two For all employees of rosuvastatin calcium post H0-SOP-01002 05 " GMP Training on management procedure of original records, emphasizing the accuracy of records.<br>