2019年6月28日，车间主管应海超在查阅来曲唑（B工艺）工艺规程 H

On June 28, 2019, the workshop supervisor, Ying Haichao, found that Letrozole (process B) process specification H3-MPD-10108 02 edition found that the content of the process specification on page 3, item 1.8 (production packaging: loading finished products Inside the two-layer film bag, it is electrically sealed, put in a 10Kg aluminum can, capped and sealed, and labeled. Sales packaging: put the finished product in a two-layer film bag, electrically sealed, placed in 1Kg, 5Kg or 10Kg aluminum can Cover and seal, label, and finally put into a carton, and then label.) Aluminum can specifications (1kg, 5kg, 10kg) and letrozole (process B) product material information H3-MPD-10108-A12 05 version The specifications of the aluminum cans (1kg, 2kg, 5kg) are not consistent. <br><br>The root cause of the inconsistency between the aluminum can specification information and the product material information in the letrozole (process B) process specification is that the workshop personnel in the process of drafting the product material information (including packaging materials) as an annex to the process specification, in the process A part of the aluminum can specification information is still left in the text of the specification, and the subsequent workshop personnel did not check the process specification file again when checking the process documents related to the product aluminum can specification change, and mistakenly believed that the material no longer covered in the process specification. The reviewers did not review the results, which caused the aluminum can specifications in the process specification not to be updated to the latest status. <br><br>This deviation is caused by the product process regulations not being revised in time when the aluminum can specifications for product production / sales have changed. The product material information, packaging operation regulations and batch production records involved in the changes have been revised in time. There are no abnormalities in the records of aluminum cans, which have no effect on product quality. The information about the registration and reporting of the products involved in the verification has been updated as required without any abnormalities. <br><br>1. Revised H3-MPD-10108 "Letrozole (Process B) Process Regulations" 02 edition, delete the aluminum can specifications related information in the body of the process regulations, the specific aluminum can specifications can be found in the process regulations annex-product material information. <br>2. Revised H3-MPD-10329 "Letrozole Process Specification (Process B South Line)" version 00, delete the aluminum can specification related information in the body of the process specification, the specific aluminum can specification can be seen in the process specification annex-product material information.<br>3. Train workshop related personnel and auditors with H3-SOP-01007 "Process Specification Development and Management Procedures" version 05 training, emphasizing that the material information in the process specification body should be transferred to the attachment of the process specification. <br>4. Train the relevant personnel on H0-SOP-01001 "document preparation and management procedures" version 07, emphasizing the principle of systematic, dynamic, rigorous and traceability of document preparation.

2019年6月28日，车间主管应海超在查阅来曲唑（B工艺）工艺规程 H3-MPD-10108 02版时发现，工艺规程第三页1.8项下内容（生产包装：将成品装入二层薄膜袋内，电热封口，放在10Kg铝罐内压盖封口，贴上标签。销售包装：将成品装入二层薄膜袋内，电热封口，放在1Kg、5Kg或10Kg铝罐内压盖封口，贴上标签，最后装入纸箱，再贴上标签。）中的铝罐规格（1kg、5kg、10kg）与来曲唑（B工艺）产品物料信息H3-MPD-10108-A12 05版中的铝罐规格（1kg、2kg、5kg）不一致。 <br><br>导致此次来曲唑（B工艺）工艺规程中铝罐规格信息与产品物料信息不一致的根本原因为车间人员在将产品物料信息（包括包材）单独作为工艺规程附件的起草过程中，在工艺规程正文中仍遗留一部分铝罐规格信息，而后续车间人员在排查产品铝罐规格变更涉及的工艺文件时未再次对工艺规程文件进行核查、误认为工艺规程中已不再涵盖物料相关信息。审核人员未审核到位，致使工艺规程中铝罐规格信息未更新至最新状态。 <br><br>此次偏差为产品生产/销售用的铝罐规格发生变更时产品工艺规程未及时进行修订导致，变更涉及的产品物料信息、包装操作规程及批生产记录均已及时完成修订，查看车间领用的铝罐记录均无异常，对产品质量无影响。核查涉及的产品注册上报信息，均已按要求更新、无异常。 <br><br>1.修订H3-MPD-10108“来曲唑（B工艺）工艺规程”02版，删除工艺规程正文中的铝罐规格相关信息，具体铝罐规格可见工艺规程附件——产品物料信息。<br>2.修订H3-MPD-10329“来曲唑工艺规程（B工艺南线）”00版，删除工艺规程正文中的铝罐规格相关信息，具体铝罐规格可见工艺规程附件——产品物料信息。<br>3.对车间相关人员及审核人员进行H3-SOP-01007“工艺规程的制定及管理程序”05版的培训，强调工艺规程正文中物料信息应转入工艺规程的附件中。<br>4.对相关人员进行H0-SOP-01001“文件编制及管理程序”07版培训，强调文件编制的系统性、动态性、严密性、可追查性原则。

On June 28, 2019, the workshop supervisor Ying Haichao found out under 1.8 on the third page of the process specification (production packaging: put the finished product into the second layer film bag, heat seal, put it in the 10kg aluminum tank for gland sealing and label) when consulting the h3-mpd-10108 02 version of the process specification of letrozole (B process). Sales packaging: put the finished products into two-layer film bags, seal them with electric heating, put them in 1kg, 5kg or 10kg aluminum cans, seal them with gland, affix labels, finally put them into cartons, and affix labels.) The specifications of aluminum tanks (1kg, 5kg, 10kg) in are inconsistent with the specifications of aluminum tanks (1kg, 2kg, 5kg) in h3-mpd-10108-a12 version 05 of letrozole (B process) product material information.<br>The root cause of the inconsistency between the aluminum tank specification information and the product material information in letrozole (B process) process specification is that in the process of drafting the product material information (including the package material) as an attachment of the process specification, some aluminum tank specification information is still left in the process specification body, while the subsequent workshop personnel are checking the work involved in the product aluminum tank specification change During the process document, the process procedure document was not checked again, and the material related information was no longer included in the process procedure. The reviewers did not audit in place, resulting in the aluminum tank specification information in the process specification was not updated to the latest status.<br>This deviation is caused by the product process specification not being revised in time when the specification of aluminum cans for product production / sales is changed, the product material information, packaging operation specification and batch production record involved in the change have been revised in time, and the records of aluminum cans collected in the workshop have no abnormality, which has no impact on product quality. The product registration information involved in the verification has been updated as required without exception.<br>1. Revise h3-mpd-10108 "letrozole (B process) process specification" version 02, delete the relevant information of aluminum tank specification in the process specification body, and see the annex of process specification product material information for specific aluminum tank specification.<br>2. Revise h3-mpd-10329 "letrozole process specification (south line of process B)" version 00, delete the relevant information of aluminum tank specification in the process specification body, and see the annex of process specification product material information for specific aluminum tank specification.<br>3. Train the workshop related personnel and auditors on h3-sop-01007 "process procedure formulation and management procedure" version 05, emphasizing that the material information in the process procedure body should be transferred to the attachment of the process procedure.<br>4. Conduct h0-sop-01001 "document preparation and management procedure" version 07 training for relevant personnel, emphasizing the systematic, dynamic, rigorous and traceable principles of document preparation.<br>