2019年09月23日10:34，人员程茂松在盐酸多柔比星粗品生产现场

At 10:34 on September 23, 2019, personnel Cheng Maosong found that the crude product of doxorubicin hydrochloride (crystallization, drying) was found at the production site of crude doxorubicin hydrochloride, when consulting the relevant documents such as the operating procedures of the doxorubicin hydrochloride post The version of the operating procedure is H3-SOP-10298-04 (Version 03), and the correct document number of the post-operational procedure of crude doxorubicin hydrochloride (crystallization, drying) should be H3-MPD-10298-04. <br><br>The initial version of the post-operation procedure document number of crude doxorubicin hydrochloride (crystallization, drying) has an error, so personnel Zhong Haibin revised the H3-SOP-10298-04 post-operation procedure of crude doxorubicin hydrochloride (crystallization, drying) , Directly copied the file number of the previous version (version 02). During the subsequent revision, only the relevant content in the post operation regulations was concerned, the file number was not carefully checked, and the reviewer and approver were not carefully checked. <br><br>1. The file numbers of the other operating procedures of doxorubicin hydrochloride and the operating procedures of epirubicin hydrochloride may be at the same risk. Through a one-by-one investigation, it is determined that there are no similar errors in the file numbers of other files. <br>2. There may be a risk that the wrong document number of the doxorubicin hydrochloride crude product post is quoted, leading to errors in other documents. After checking, it is determined that the document number has not been cited. <br>3. Check the content of the post-operation regulations (version 03) of crude doxorubicin hydrochloride (crystallization, drying) with deviations in the document number. The content information is correct, and the product production can be correctly guided without affecting the quality of the product. <br><br>1. Revise the document number H3-SOP-10298-04 of the post-operation rules (version 03) of crude doxorubicin hydrochloride (crystallization, drying) to H3-MPD-10298-04, and upgrade the document. <br>2. Check the file numbers of the other operating procedures of doxorubicin hydrochloride and the operating procedures of epirubicin hydrochloride one by one, and make sure that there are no similar errors in the file numbers of other files. <br>3. Retraining relevant personnel on H0-SOP-01001 document preparation and management procedures, requiring personnel to ensure that the document format is correct during document drafting and review, such as the consistency and integrity of document coding and naming principles.

September 23, 2019 10:34, personnel Cheng Maosong in hydrochloric acid dojoothan star crude production site, check the hydrochloric acid more soft than star post operating procedures and other relevant documents, found that hydrochloric acid more soft than star coarse (crystal, dry) The post operating procedure version is H3-SOP-10298-04 (03), and the correct document number of the job operating procedure of hydrochloric acid is H3-MPD-10298-04. <br><br>The initial version of hydrochloric acid polysoft than star crude (crystalline, drying) post operating procedures file number error, so the person zhong haibeline in the revision of H3-SOP-10298-04 hydrochloric acid polysoft than star rough (crystalline, drying) post operating procedures, directly copied the previous version (02 version) of the document number, the subsequent revision, only concerned about the relevant content in the post operating procedures, not carefully review the number. <br><br>1. Hydrochloric acid more soft than star other post operating procedures and hydrochloric acid table soft than star post operating procedures may have the same risk of error, through one by one troubleshooting, to determine that other files of the file number did not appear similar errors.<br>2. There may be hydrochloric acid polysoft than star rough post operating procedures error file number is referenced, resulting in other documents error risk, after checking, to determine that the file number did not appear to be referenced.<br>3. View the contents of the operation procedure (03) of the position of hydrochloric acid, which is biased in the number of this document, its contents are correct and can correctly guide the production of the product, which has no effect on the quality of the product.<br><br>1. Revise the document number H3-SOP-10298-04 of the document number H3-SOP-10298-04 of the post procedure (03) of hydrochloric acid polysoft than star crude material (crystalline, drying) to H3-MPD-10298-04, and upgrade the file.<br>2. The file number of the hydrochloric acid more soft than star other post operating procedures and the hydrochloric acid table soft than star post operating procedures is checked one by one, to determine that the file number of other files does not appear similar errors.<br>3. Retraining of H0-SOP-01001 documentation and management procedures for relevant personnel, requiring personnel to ensure that the document format is correct when drafting and reviewing documents, such as document coding, consistency and integrity of naming principles.

At 10:34 on September 23, 2019, when Cheng Maosong was at the production site of doxorubicin hydrochloride, looking up the post operation procedures of doxorubicin hydrochloride and other relevant documents, he found that the version of post operation procedures of doxorubicin hydrochloride (crystallization, drying) was h3-sop-10298-04 (version 03), while the correct document number of post operation procedures of doxorubicin hydrochloride (crystallization, drying) should be h3-m PD-10298-04。<br>The original version of doxorubicin hydrochloride (crystallization, drying) post operation procedure document number is wrong, so when Zhong Haibin revised h3-sop-10298-04 doxorubicin hydrochloride (crystallization, drying) post operation procedure, he directly copied the document number of the previous version (version 02). In the subsequent revision, he only paid attention to the relevant content in the post operation procedure, but did not Carefully check the number of documents, and the reviewer and approver do not check carefully.<br>1. There may be the same risk of errors in the document numbers of other post operation procedures of doxorubicin hydrochloride and those of the post operation procedures of doxorubicin hydrochloride. Through checking one by one, it is determined that there is no similar error in the document numbers of other documents.<br>2. It is possible that the wrong document number of doxorubicin hydrochloride rough product post operation procedure is quoted, which leads to the risk of errors in other documents. After checking, it is determined that the document number is not quoted.<br>3. Check the content of the operation procedures (version 03) of doxorubicin hydrochloride crude product (crystallization and drying) post with the deviation of the document number. The content information is correct, which can guide the production of the product correctly and has no impact on the product quality.<br>1. Revise the document No. h3-sop-10298-04 of doxorubicin hydrochloride (crystallization, drying) post operation procedure (version 03) to h3-mpd-10298-04, and upgrade the document.<br>2. Check the document numbers of other post operation procedures of doxorubicin hydrochloride and those of the post operation procedures of doxorubicin hydrochloride one by one, and make sure that there is no similar error in the document numbers of other documents.<br>3. Conduct retraining on h0-sop-01001 document preparation and management procedures for relevant personnel, and require personnel to ensure that the document format is correct during document drafting and review, such as consistency and integrity of document coding and naming principles.<br>