In 2018, I joined Yangzijiang Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., LTD., becoming a member of this big family. I still remember the hot July sun in Taizhou, the headquarters of the group. We who participated in military training sweated like rain under the European corridor, and the inculcated leaders in the Haiyan banquet hall...... It has given the new college students an unforgettable memory, and what is engraved in the depths of everyone's memory and will accompany everyone for life is how to be a Yangzijiang pharmaceutical person.

I have been in contact with the M generic drug project since my internship. It is very easy for the laboratory to make small batches of apis, but it is difficult to optimize a route suitable for industrial production. Industrialization also means that any step should be controllable and repeatable, seemingly simple requirements, but need a large number of experimental data support, repeat N+1 experiments and continuous verification. In the face of psychological frustration again and again, again and again, if it is not the heart of the stick, how to move forward calmly.

At the beginning of 2019, the process optimization of M API was nearing completion. We are all excited to analyze the report of our colleagues. If there is no problem with the report, it basically means that our work for the whole year will come to a successful end. Each time the analysis colleagues tested a project, they gave us feedback, so the results of the content, character, acidity, relevance, residue, moisture, heavy metals and other detection items were feedbacks one by one, and everyone's heart would be relaxed for each project that passed the test.

But success is often not that simple. At the end of the test, when everyone was ready to celebrate, the analysis colleagues reported that the clarity test was not qualified, that is, there were very small foreign bodies visible to the naked eye in the solution. How is that possible? Everyone did not want to believe this result, our process route contains multiple filtration steps, theoretically analysis is impossible to appear foreign bodies.

"No difficulty can beat us, only quality." So we re-sorted the process, researched the literature, and repeatedly tested the finished product of M raw material. After half a month's effort, it was determined that the possible source of visible foreign bodies was mechanical impurities and polymerization products under specific conditions of M raw material. The problem was then solved by re-designing the process for both sources, adding specific compounds to remove ions that could trigger polymerization, and setting up a filtration process to remove mechanical impurities at the final stage of the process.

This project won the first prize in the 40th National Pharmaceutical industry QC Group results presentation exchange meeting. Looking back on this experience, what I have learned is not only the professional knowledge of various research links, but more importantly, how to become a qualified Yangzijiang Pharmaceutical person!