2019年 08月14日下午15:20分，生产操作人员陶奇在Y69N二

At 15:20 in the afternoon of August 14, 2019, production operator Tao Qi weighed the weight of the 9110-F190801 batch of gibberellin once refined products on the second floor of Y69N, and found that the weight of the weighed one refined wet product was 88.57kg, not It meets the requirement of 100-120kg wet product refined by gibberellol at one time. <br><br>This deviation occurs due to the unreasonable weight regulation of the refined wet product and the low speed centrifugation time set in the third batch is too long, resulting in the low weight of the wet material of the refined product, which exceeds the record range. <br><br>After the deviation occurs, there is no influence on the feeding and crystallization process control of the subsequent secondary refining production of gibberellol. Through data analysis, this deviation has no effect on the quality of the primary refined product. The weight of the crude wet material and the range of the wet material weight of the primary refined product in the primary refined product of gibberellol (from H11-PDR-10002-01R "Gibberellin R & D Report" magnified at the same scale) are not significant and are non-key indicators , Only for reference, it is recommended to cancel this weight range. For details, please refer to D-TZ-API-01ZE-19002-R Gibberellin Deviation Survey and Risk Assessment Report for risk analysis and impact assessment. <br><br>1. In the revalidation report of the gibberellin process, it is necessary to discuss and analyze all the centrifugation time of gibberellin, and output the centrifugation control time in the report. <br>2. After the gibberellin process revalidation report is approved, upgrade H3-MPD-10252-14 "Gibberellol Primary Refinery Post Operation Regulations (Y69)", add the provisions of centrifugation time, and train personnel, emphasizing Time needs to be controlled within the required range. <br>3. Change the weight range of wet materials in the production process of gibberellin, and upgrade the relevant SOP related to the weight range of wet materials, and train all production personnel.

August 14, 2019 at 15:20 p.m., production operator Tao Qi weighed 9110-F190801 batches of erythromycin on the second floor of Y69N, found that the weighing of a refined wet product weight of 88.57 kg, does not meet the requirements of chimysteromel sp), a refined wet product 100 to 120 kg. <br><br>The deviation occurred due to the unreasonable weight regulations of a refined wet product, and the low-speed centrifugation time set by the third batch is too long, resulting in a fine product wet material weight is low, beyond the record range. <br><br>After the deviation occurs, there is no effect on the process control of the feeding and crystallization process of the subsequent two-stage refined production of erythromycin, and through the data summary analysis, the deviation has no effect on the quality of a refined product. The weight of coarse wet material signed by chimylool once refined products and the weight range of wet material of a refined product (from H11-PDR-10002-01R "Chimynool Research and Development Report" amplification) are of little significance, are non-critical indicators, only as a reference, it is recommended to cancel the weight range. See The Risk Analysis and Impact Assessment of d-TZ-API-01ZE-19002-R Erymyxol Bias Investigation and Risk Assessment Report. <br><br>1. In the report of erythromycin process revalidation report, it is necessary to discuss and analyze all centrifugal times and output centrifugal control time in the report.<br>2. After approval of the red mildew process revalidation report, the upgraded H3-MPD-10252-14 "Chimygal once fine products post operating procedure (Y69)", add the requirements of centrifugal time, and training personnel, emphasizing that centrifugal time needs to be controlled within the required range.<br>3. Change the weight range of wet materials in the production process of erythromycin, and upgrade the relevant SOP involving the wet material weight range, and train all production personnel.

At 15:20 p.m. on August 14, 2019, when Tao Qi, the production operator, weighed 9110-f190801 batches of primary refined products of Gibberellin on the second floor of y69n, it was found that the weight of primary refined wet products was 88.57kg, which did not meet the requirements of 100-120kg primary refined wet products of gibberellin.<br>The reason for the deviation is that the weight of the wet product in the primary refining is unreasonable and the low-speed centrifugation time set in the third batch is too long, which leads to the low weight of the wet material in the primary refining and beyond the recording range.<br>After the deviation, there is no impact on the feeding and crystallization process control of the subsequent secondary refining production of gibberellin; through data collection and analysis, the deviation has no impact on the quality of primary refined products. The weight range of primary refined products and primary refined products (from h11-pdr-10002-01r "research and development report of gibberellin" with the same scale amplification) specified in primary refined products of gibberellin are of little significance. They are non key indicators and are only used for reference. It is recommended to cancel the weight range. See d-tz-api-01ze-19002-r gibberellin deviation survey and risk analysis and impact assessment report for details.<br>1. In the revalidation report of gibberellin process, all the centrifugation time of gibberellin should be discussed and analyzed, and the centrifugation control time should be output in the report.<br>2. After the approval of the revalidation report of gibberellin process, upgrade h3-mpd-10252-14 gibberellin primary refined products post operation specification (y69), add the provisions of centrifugation time, and train the personnel, emphasizing that the centrifugation time needs to be controlled within the required range.<br>3. Change and cancel the weight range of wet materials in the production process of gibberellin, upgrade the SOP related to the weight range of wet materials, and train all production personnel.