The road to success is bound to be covered with thorns, through the wind and rain to see the rainbow. Research and development is taking a road that has never been taken before, and no one knows what lies ahead. When there is no way after the mountain is heavy, it is more necessary to calm down to analyze the problem and concentrate on solving the difficulties.

Under the leadership of Dr. Chen Dong, the members of the team adopted the method of single factor investigation to conduct experiments and demonstration analysis. Single-factor investigation means that a large number of tests are needed to investigate the causes one by one, and in the face of the complicated test process, everyone does not flounce, but becomes more courageous. Through dozens of tests, analysis and verification, finally get the main factors affecting product quality, and according to the principle of 5W1H to implement countermeasures, to find the best prescription process of M product.

The most difficult thing in research and development is whether people can settle down and continue to learn, improve and challenge themselves. The implementation of the countermeasure has brought hundreds of sets of data, which requires a lot of time and energy to summarize, verify and analyze. After repeated verification, SPSS software is used to obtain fitting equations. After regression analysis, origin9 software is used to draw three-dimensional effect surface maps and two-dimensional contour maps, and the optimal regions of each effect surface are overlapped. DOE determined the design space of process parameters and finally determined the optimal process parameters of M product.

At the stage of effect inspection, the stability test results of 3 confirmed batches of product M showed that the content of impurity A was successfully reduced to the predetermined target and was lower than that of the original drug. At the same time, under long-term and accelerated conditions, the impurity content meets the ICH limit (0.2%). Through this technical research, the quality of the self-produced products is ensured to be consistent with the original products, in line with international standards, and in line with the requirements of injection consistency evaluation.

According to the data from Beijing Haiyan HR, the average daily working hours of the Institute of Drug Research have always been at the forefront of the working hours data statistics of each month throughout the year. Everyone is conscious of the initiative to work overtime, rush time, catch up with the progress.

The effort eventually pays off, and the Haiyue QC team won the first prize and the best Individual publication award at the 39th National Pharmaceutical Industry QC Group Results Publication Exchange meeting.