由于H3-SOP-41004生产设备清洗管理规程（07版）已升版，转产

Since the H3-SOP-41004 production equipment cleaning management regulations (version 07) has been upgraded, the transfer cleaning personnel do not have enough understanding of the latest version of the production equipment cleaning management regulations, and the judgment on the conversion cleaning time is wrong, which ultimately leads to the Tigrillo production line The cleaning process of the production transition exceeds the specified time. This deviation was caused by personnel reasons and was the first time after the SOP was upgraded. <br><br>By checking the stability verification report of ticagrelor H3-VD-00420R, ticagrelor intermediate TCG1 is stable within 30 days, and the residence time of this cleaning transfer is 23 days, confirming the residual ticagrelor intermediate The body remains unchanged, and it has no effect on the cleaning effect; at the same time, check the cleaning record of the conversion, all parameters meet the cleaning requirements set by the plan, no abnormalities occur during the cleaning process, and no residues are visually observed after the cleaning, according to H3-VD-40490-RVP -A04 ticagrelor flash point study, after visual inspection, the residual concentration of the reaction tank may be less than 4ug / cm2, and the acceptance standard of the residual concentration of the reaction tank is 504ug / cm2. Therefore, the concentration of the residue after passing the visual inspection is far less than the acceptance standard, so the residue after cleaning does not affect the next product. In summary, this deviation has no effect on product quality. <br><br>CP-TZ-API-D-TZ- <br>API-11TI-19001-20001: H3-SOP-41004 production equipment cleaning management regulations (version 07) and H0-SOP-10001 employee training management procedures (version 06) Training. Emphasis: 1. For production lines / regions with collinear products, at the end of a production stage, if there is no follow-up production plan, you must first arrange for conversion cleaning, and each step of conversion cleaning needs to be in the last equipment batch of the process / post Completed within 3 days after the end of cleaning. 2. Employees need to study carefully during the training, and strive to improve their personal knowledge, skills, skills, and constantly improve their personal level.

As H3-SOP-41004 production equipment cleaning management procedures (07 version) has been upgraded, transfer cleaning personnel on the latest version of the production equipment cleaning management procedures do not know enough, the transfer of cleaning time error, and ultimately lead to the production of the Greilo production process more than the specified time. This deviation is due to personnel reasons and occurs for the first time since the SOP is promoted. <br><br>By looking at the H3-VD-00420R for grillo intermediate stability verification report, it can be seen that the TCG1 of the tigrelo intermediate is stable within 30 days, the stay time of this transfer cleaning is 23 days, confirms that the residual Tigrelo intermediate remains unchanged, has no effect on the cleaning effect, and at the same time, the transfer cleaning record, all parameters are in line with the cleaning requirements set by the scheme. , no abnormal situation occurred in the cleaning process, no residue after cleaning, according to H3-VD-40490-RVP-A04 for the Grillo flash point study, the detection of qualified reaction tank may have a residual concentration of less than 4ug/cm2, and the reaction tank residue concentration is accepted standard of 504g/cm2. Therefore, the concentration of residues after the inspection is well less than the acceptance standard, and the residual substance after cleaning does not affect the next product. To sum up, this deviation has no effect on product quality.<br><br>CP-TZ-API-D-TZ-<br>API-11TI-19001-20001: Training of relevant personnel in the H3-SOP-41004 production equipment cleaning management procedures (version 07) and H0-SOP-10001 employee training management procedures (version 06). Emphasize: 1, for the production line/region of the common line products, the product at the end of a production phase, if the subsequent production plan is not clear, must first arrange for the transfer of production cleaning, and each step of transfer cleaning needs to be completed within 3 days after the end of the last equipment batch cleaning of the process / post. 2, employees in the training need to study seriously, and strive to improve personal knowledge, skills, skills, and constantly improve personal level.

As h3-sop-41004 production equipment cleaning management procedure (version 07) has been upgraded, the production equipment cleaning personnel did not fully understand the latest version of the production equipment cleaning management procedure, and the judgment of the production equipment cleaning time was wrong, which ultimately led to the production equipment cleaning process of tegrilo production line exceeding the specified time. The deviation was caused by personnel and was the first time since the SOP was upgraded.<br>It can be seen from h3-vd-00420r stability verification report of tegrilol intermediate that tcg1 of tegrilol intermediate is stable within 30 days, and the retention time of this transfer cleaning is 23 days. It is confirmed that the residual tegrilol intermediate remains unchanged, which has no impact on the cleaning effect. At the same time, check the transfer cleaning record, all parameters meet the cleaning requirements set in the scheme, and there is no abnormal situation in the cleaning process There is no residue after cleaning. According to the flash point study of h3-vd-40490-rvp-a04 tegrilol, the concentration of residue in the reaction tank may be less than 4ug / cm2 after passing the visual inspection, while the acceptance standard of the concentration of residue in the reaction tank is 504ug / cm2. Therefore, the concentration of residue after visual inspection is far less than the acceptance standard, so the residue after cleaning will not affect the next product. To sum up, this deviation has no impact on product quality.<br>CP-TZ-API-D-TZ-<br>Api-11ti-19001-20001: train relevant personnel in h3-sop-41004 production equipment cleaning management procedure (version 07) and h0-sop-10001 staff training management procedure (version 06). Emphasis: 1. For the production line / area with common line products, if the follow-up production plan is not clear at the end of a production stage, the production transfer cleaning must be arranged first, and each step of production transfer cleaning shall be completed within 3 days after the last equipment batch cleaning of the process / post. 2. In the training, employees need to study hard to improve their personal knowledge, skills and skills, and constantly improve their personal level.