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Daily accumulation is the cornerstone of paving the road to success

Release time:

2021-03-12

Pharmaceutical Company 2020 Outstanding Scientific and Technological Worker Pharmaceutical Company Product Development Department Liu Yang

I have been engaged in the research and development of bulk drugs since I entered the company in 2013 . I cherish the title of "Tech Worker " , because to have technology is to have the power of innovation, to create unlimited possibilities. Therefore, as workers in the pharmaceutical industry, we must have a pattern that is in line with the domestic first-class pharmaceutical companies, and we must also dare to establish the ideal of catching up with the world's advanced level of medicine. We have the responsibility and ability to make technological breakthroughs become an important force in the development of our enterprises. After so many years of research and development work, I know very well that the nature of scientific and technological work requires the accumulation of a lot of basic work, repeated verification and attention to details, and finally qualitative changes can be caused by quantity.

Looking back on the past year, it was full and full of difficulties and challenges. Last year, it was notified in January 19 that the National Evaluation Center would conduct on-site verification of the esomeprazole sodium project we declared in February 21 4 . However, the process of raw materials has not been verified on the modified equipment. It only took more than 3 months and the Spring Festival holiday in the middle. We only had the chance to find problems in production in batch 1 trial production. We used batch 2 to verify the feasibility of the production plan. Batch 4 as the on-site dynamic verification batch must be safe. During the trial production, there were many problems, such as excessive impurities in the products and blocking materials during the preparation of intermediates. It can be said that the operation of the trial production process was not smooth, and the quality of the products obtained was not good. As soon as the trial production is over, we will summarize all the problems in time and analyze the reasons step by step. For example, the impurity exceeding the standard is due to the key process of the project: the reaction conditions required for oxidation reaction are relatively harsh, and the new equipment in the workshop cannot do experiments like in the laboratory, and the temperature control and feeding are very accurate. While we were discussing how to increase the ability of equipment control through small improvements, we were thinking hard about other countermeasures, and the on-site operator said: "This side of the fine process is simply not suitable for large-scale production! " This sentence made me suddenly realize that I used to think that the more detailed and accurate the process, the better, but now it seems to be a misunderstanding. Because if the operating parameters of a process are very accurate, every production should be more careful, which will undoubtedly increase the risk of production failure. However, if the parameters of the process are in a very wide range, the operator can ensure the product quality as long as he follows the relevant procedures and does not need very fine operation. Of course, the process with wide parameters is better. Therefore, with this idea in mind, I came back to consult the literature, read the summary of previous experiments, analyzed the reaction conditions of the oxidation process one by one, and proved my idea through 10 batch of small-scale experiments. After that, the conditions for the oxidation reaction were appropriately relaxed, and at the same time, with the improvement of equipment, in the following batches of production, the key process was basically stable, impurities were controllable, and the reaction law was clear.

In addition, the problem of intermediate blocking the pipeline occurred during the trial production, which not only affected the quality and yield of the product, but also increased the difficulty of the production operation. A simple crystallization rejection and filtration process can be completed in normal

2 hours, and our trial production took more than 8 hours. This intermediate itself is easy to agglomerate quickly. We have many methods to deal with agglomeration in the laboratory trial production process, but it is completely impossible to enlarge the production. If this difficult problem is not solved, the on-site verification will definitely fail. In the face of this problem, I pondered hard for a few days. The experimental phenomena that I had done before kept flashing in my mind. It suddenly occurred to me that this intermediate had a very short forming period when it was separated out. The key to solving the agglomeration lies in this short forming period. It hasn't come out earlier, and it has already formed hard lumps if it is later, so when I do this step of production, I will keep a close eye on the forming time. As soon as the forming period arrives, I will immediately increase the stirring speed and cooperate with the impact of the air flow to prevent the material from forming hard lumps. Finally, after 2 batch production attempts, the problem was successfully solved and the production cycle was greatly shortened.

Through the concerted efforts of various departments, esomeprazole sodium successfully passed the on-site dynamic inspection in

4 and the compliance inspection of GMP in 11 , and successfully obtained the production license. In addition to the esomeprazole sodium project, last year I also did a lot of work for the verification of imatinib mesylate application, which ensured the smooth progress of the verification production now.

shared so much, I think as a scientific and technological worker, we should not only have lofty ideals and firm confidence, but also pay attention to basic work, be patient and not let go of details. Ideal and confidence are like road signs, and the accumulation of daily work is the cornerstone of paving the road to success. The two complement each other and are indispensable. Only in this way can we truly achieve

"to set up a peak ambition and make a high-quality medicine " , turn our work into an important part of promoting the development of the company and grow together with the enterprise.

(according to Liu Yang's speech at the summary commendation meeting of the pharmaceutical company)

More information

Spike New Drug Approved for Registration

On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)

2020

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Peak International Trade was rated as "excellent delivery warehouse" by the big business"

On April 12, the 2019 Dalian Commodity Exchange Industrial Products Delivery Work Summary Meeting was held in Dalian. Jianfeng International Trading Company was rated as "2018 (Industrial Products) Excellent Delivery Warehouse" and Ruan Weihang, an employee of the International Trading Company, was rated as "2018 (Industrial Products) Excellent Futures Specialist in Designated Delivery Warehouse". The delivery link is the bridge link between the futures and cash markets, an important area of risk prevention and control in the futures market, and a strong guarantee for the smooth operation and function of the market. Since obtaining the qualification of PVC delivery warehouse in 2009, the chemical warehousing and logistics business of international trading company has developed steadily. In terms of management, the international trading company strictly follows the various systems of the Dalian Commodity Exchange to implement warehouse-in and warehouse-in management. The management level has been improved year by year. Broken packages have been handled on the spot, and the loss of goods has been greatly reduced. The management goal of daily clearing has been achieved, and standardized operations have been achieved; in terms of business marketing, the futures business has driven the gradual development and growth of the spot business, futures varieties have developed from a single PVC variety to four varieties of PVC, PP, PE and plywood. The business volume has increased year by year and has exceeded 500000 tons. The operation volume can exceed 2500 tons/day; In terms of customer service, from zero experience in futures business to now, customer reputation has increased year by year, and customer complaints have gradually decreased. The annual excellent delivery warehouse of the judges is the full affirmation of Dalian Commodity Exchange on the functions of international trading companies, market satisfaction, futures management level and standardization of warehouse daily management. Lou Chunming, general manager of the international trading company, said that the international trading company will implement

2020

07-31

Spike New Drug Approved for Registration

2020

07-30

Peak Cement Won the Bid for National Key Project Daye Peak Becomes Huang-Huang Railway Supplier

On March 19, Daye Jianfeng Cement Company officially received a notice from China Railway Construction Material Collection Center that the company was shortlisted for the new Huang (Mei) Huang (Zhou) railway project in the Hubei section of the Shanghai-Chengdu high-speed railway along the Yangtze River in the second place, and obtained the right to supply the 6th package of cement. This is the first stick undertaken by Daye Jianfeng in 2019, and it is also the second time to enter the high-speed rail project after the Wu (Han) Jiu (Jiang) high-speed rail. The Huanghuang high-speed railway is a component of the "eight vertical and eight horizontal" high-speed railway network in the "National Medium and Long-term Railway Network Plan". It is a component of the Wuhan-Hangzhou and Beijing-Hong Kong-Kowloon high-speed railway network. It has a total length of 125 kilometers and a design speed of 350 kilometers per hour. It will start construction at the end of 2018. It will be opened to traffic in 2021. In addition to the characteristics of large demand for high-speed railway and highway projects, the project time span is long and the product quality requirements are high, especially the high-speed railway project has extremely strict requirements on the alkali content of cement. After participating in the bidding, Yuan Xianming, executive deputy general manager of Daye Peak, organized production, quality control, procurement and other relevant departments for many times to carry out tests on the production of low-alkali cement and adjust the proportion of raw materials. The quality control department also sent samples to the provincial professional inspection department for comparative inspection to ensure product stability. The marketing department carefully checked the details of the tender, strictly checked and repeatedly deduced the bid price. Finally, with the full cooperation of all departments, the successful bidding was passed, finalist Huang-Huang high-speed rail project. It is understood that as the country continues to increase investment in infrastructure transportation construction, daye peak adjusted its work direction at the end of 2018, requiring marketing work in 2019 to focus on key projects.

2020

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Daye Peak Opens "Standard Year"

After the 2019 overhaul ended in early March, Daye Jianfeng Cement Company immediately launched the "Standard Year" activity to carry out standardized rectification in view of a series of defects and problems in the daily management process. The goal of the "Standard Year" activity is to target specific issues that affect employees' work efficiency and safe and environmentally friendly production. Through the formulation of institutionalized work standards, further standardize employees' various operations, improve operational efficiency, and improve grassroots management execution, so as to achieve The purpose of improving the company's image, reducing costs, improving efficiency, and increasing benefits. In order to ensure the smooth progress of the activities, daye peak has set up a promotion team headed by general manager Zhang fengliang to be responsible for the overall promotion of the "standard year" activities, mainly including revising the activity plan, summarizing the standardized implementation standards of various departments, implementing the plan, supervising the implementation progress, evaluating the implementation effect, collecting suggestions and opinions in the implementation process, etc. Based on the foundation, aiming at the details and solving problems is a major feature of Daye peak's "standard year" activity. For example, the "Flange Sealing Operation Standard", which is currently being tried out, not only puts forward standardization requirements for such a "trivial matter" in equipment management as flange sealing, but also attaches "model" photos to make it clear to mechanics What should be done and what should be done. However, this "small standard" aims at three problems: leakage at the production site, extensive mechanic work and waste of materials. Once it becomes the behavior habit of employees, the hygiene and cost control at the production site are bound to be improved. It is understood that Daye peak "standard year" activities plan to continue for three years to promote, activities

2020

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Daye Peak Opens "Standard Year"

2020

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