2019年05月13日上午10：23分，207车间王如魁在QA办公室翻

At 10:23 am on May 13th, 2019, Wang Rukui, workshop 207, looked at the gibberellin 9110-F180601 batch records in the QA office and found that the batch H3-MPD-10252-R05 version 02 "Gibberellin hydrogenation post batch The production record of 10% palladium carbon in the production record stipulates that the feeding amount range is 18.0 ± 1.0kg, and the 10% palladium carbon feeding amount range obtained by the calculation formula is 15.5 ~ 17.6kg, the two feeding ranges are inconsistent. (Remarks: TDS refers to total dissolved solids, the range is 180 ~ 204kg). <br><br>This deviation occurs because the drafters of "Gibberellin Primary Refined Product Batch Record" output wrong calculation formula of 10% palladium carbon when drafting, resulting in the calculation formula 18.0 × (1-palladium carbon moisture%) × TDS / gibberene The 10% palladium carbon charge range calculated by the weight of ketone x 95.7% (average yield of 95.7% trial production reduction) is inconsistent with the theoretical charge 18.0 ± 1.0kg10% required by the SOP, and the relevant document reviewer failed to review the error due to negligence. <br><br>By comparing the quality of 3 batches of verification batches in 2015, 7 batches of normal production batches in 2018 and the quality of normal batches, it was found that the deviation involved batches and the quality of other normal batches were basically the same and all met the quality standards. The quality and yield of gibberellin produced by the relevant batches were not abnormal. It shows that these batches of 10% palladium carbon feedstock act as a catalyst in the process. According to the process risk assessment in the gibberellol pilot and pilot test R & D reports, 10% palladium carbon feedstock volume is low and there is incomplete raw material reaction. Situation, but the quality and yield of gibberellin produced by the relevant batches are not abnormal. It shows that the calculation error of the 10% palladium carbon feed volume of these batches has no effect on the production of gibberellin. <br>According to the analysis and summary of the above aspects, in the production of gibberellin primary refined products, the amount of 10% palladium carbon input is less than the calculated input, which basically does not affect the product quality. This deviation also does not affect the validity of the verification, and it is judged that the occurrence of this deviation has no potential impact on gibberellin products. <br><br>1. H3-MPD-10252-R03 ~ R08 "Gibberellin Batch Production Record (Y69)" was upgraded, and the 10% palladium carbon calculation formula was deleted.<br>2. Train the upgraded H3-MPD-10252-R03 ~ R08 "Gibberellin Batch Production Record (Y69)", emphasizing the deletion of the 10% palladium carbon calculation formula and the reference basis for the actual feeding amount .

May 13, 2019 at 10:23 am, 207 workshop Wang Rukui in the QA office to look through the chimyol 9110-F180601 batch records, found that the batch H3-MPD-10252-R05 02 version The 10% charcoal input range in the "Red Mold alcohol Hydrogenation Post Batch Production Record" is 18.0 to 1.0kg, while the 10% cocchar input range obtained by the calculation formula is 15.5 to 17.6kg, and the two input ranges are inconsistent. (Note: TDS refers to total dissolved solids, ranging from 180 to 204 kg).<br><br>The deviation occurred because the drafters of the "Chimynol Prefine product batch record" were wrong in the output of the 10% charcoal calculation formula at the time of drafting, resulting in the calculation formula 18.0 x (1-carbon moisture%) x TDS/red mysterone weight x 95.7% (95.7%) 95.7% trial production reduction average yield) calculated 10% of the carbon input range and SOP requirements of the theoretical input 18.0 to 1.0kg10% is inconsistent, and the relevant documents reviewer also due to negligence did not review the error. <br><br>By comparing the 2015 verification batch 3 batches, the quality of the normal production batch 7 batches and the normal batch in 2018, it was found that the deviation involved the batch and other normal batch testing quality is basically the same and all meet the quality standards. There were no anomalies in the quality and yield of erythromycin produced in the relevant batch. It is shown that 10% of the carbon feed of these batches acts as a catalyst in the process, according to the process risk assessment in the small trial of erythromycin and pilot research and development, 10% of the low amount of niobium carbon input has incomplete raw material reaction, but the quality and yield of erythromycin produced by the relevant batch are not abnormal. It is shown that 10% of the carbon input calculation of these batches has no effect on the production of erythromycin.<br>According to the above aspects of analysis and summary, in the production of erythromycin refined products, 10% of the amount of carbon input than the calculation of input is less, basically does not affect product quality. The deviation does not affect the validity of the verification, and the occurrence of the deviation has no potential effect on erythromycin products.<br><br>1.H3-MPD-10252-R03-R08 "Red myosterol once fine productbatch batch production record (Y69)" for upgrading, the 10% charcoal calculation formula will be removed.<br>2. Training of H3-MPD-10252-R03-R08 "Chimynool first-time fine product batch production record (Y69) " after the upgraded version, emphasizing the deletion of 10% of the coke calculation formula and the reference basis for the actual input amount.

At 10:23 a.m. on May 13, 2019, Wang Rukui of workshop 207 looked over the batch record of gibberellin 9110-f180601 in QA office, and found that the specified feeding range of 10% palladium carbon in batch production record of gibberellin hydrogenation post (h3-mpd-10252-r05, version 02) was 18.0 ± 1.0kg, while the feeding range of 10% palladium carbon calculated by the formula was 15.5 ~ 17.6kg, and the two feeding ranges were inconsistent. (Note: TDS refers to total dissolved solids, ranging from 180 to 204kg).<br>This deviation was caused by the drafter of the batch record of primary refined products of gibberellin outputting the calculation formula of 10% palladium carbon wrongly, resulting in the calculation formula of 18.0 × (1-palladium carbon moisture%) × TDS / gibberelline ketone weight x 95.7% (95.7% of the average production reduction yield) calculated 10% palladium carbon feeding range is inconsistent with the theoretical feeding 18.0 ± 1.0kg 10% required by SOP, and the reviewer of relevant documents did not audit the error due to negligence.<br>By comparing the quality of three validation batches in 2015, seven normal production batches in 2018 and normal batches, it is found that the test quality of the batches involved in the deviation is basically the same as that of other normal batches and all of them meet the quality standard requirements. The quality and yield of gibberellic alcohol produced by related batches were normal. The results show that the 10% palladium carbon feed of these batches plays a role of catalyst in the process. According to the process risk assessment in the R & D report of small-scale and pilot scale test of gibberellin, the raw material reaction is incomplete when the 10% palladium carbon feed is low, but the quality and yield of gibberellin produced by relevant batches are normal. The results show that the calculation error of 10% palladium carbon feeding amount of these batches has no effect on the production of gibberellin.<br>According to the analysis and summary of the above aspects, in the production of primary refined products of gibberellin, the feed amount of 10% palladium carbon is less than the calculated input amount, which basically does not affect the product quality. The deviation does not affect the validation validity, and it is judged that the occurrence of the deviation has no potential impact on gibberellin products.<br>1. H3-mpd-10252-r03 ~ R08 batch production record of primary refined products of gibberellin (y69) was upgraded, and the calculation formula of 10% palladium carbon was deleted.<br>2. Train the upgraded h3-mpd-10252-r03 ~ R08 batch production record of primary refined products of gibberellin (y69), with emphasis on the deletion of the calculation formula of 10% palladium carbon and the reference basis of the actual feeding amount.