Is it necessary to do collinear cleaning validation for insulin production?

[technical article of chinapharma.com] when I was browsing a forum recently, I found that a netizen asked, "insulin needs to be co produced from the starting point of API to the preparation Because the therapeutic effect of insulin products is similar and there is no toxicity, is it necessary to conduct collinear cleaning verification for the production of APIs? " For this question, someone replied, "it can be done with general standards" In the insulin industry, it is believed that in theory, the cleaning verification of collinear products can be carried out only by selecting the varieties that are difficult to clean and strictly limiting Here, the difficult cleaning not only refers to the solubility, but also includes the nature, color and smell of materials In fact, it is often difficult to determine a clear variety that is difficult to clean At this time, it is even necessary to consider selecting a group of products for verification, if it is production Introduce new products in the line, so as to add a cleaning confirmation of non verified products in addition to the common line cleaning verification "Evaluate the potential risks of CO production and consider whether it is necessary to do it after evaluation It is too wasteful to do it for each variety." It is also said that if the cleaning method is the same, it can be used for varieties that are difficult to dissolve, and if the cleaning method is different, it should be used There are clear regulations for product cleaning and validation, but the industry says that it will take a lot of time, money and energy to do it for each product If the cleaning method is the same and the risk assessment is feasible, the varieties that are difficult to dissolve can be selected It is understood that for diabetic patients, insulin injection is an effective treatment to control blood sugar According to the new diabetes data released by the International Diabetes Federation (IDF) in 2017, China's diabetes population has reached 114 million, ranking first in the world In this context, China's insulin preparation products will usher in good development opportunities Although this "big cake" is in front of us, it is difficult to eat it According to the industry, the insulin production industry has high technical barriers, policy barriers, capital barriers, academic promotion barriers and product brand barriers It is difficult for enterprises lacking competitive advantages to enter the market and obtain a certain market share Among them, technical barriers include high equipment requirements and complex process routes In terms of policy barriers, China's "drug production quality management standards" and the new GMP standards have strict standards and requirements for drug production The industry pointed out that the current insulin market has a strong momentum of development and is supported by relevant national policies, but the domestic biopharmaceutical industry has problems such as insufficient innovation and R & D capacity, low-level competition and so on The author also learned that before, many enterprises in our country applied for insulin production, but they were returned due to the non conformity of the production site and GMP joint inspection It can be seen that the R & D and production barriers of insulin products are relatively high, so the development enterprises must pay attention to them Generally speaking, drugs are related to people's life safety For example, in terms of production or packaging, it is necessary to strictly follow the standards to ensure the safety of products and win the trust of more users in the market According to industry statistics, the average insulin treatment time of diabetic patients is about 12 years, and most of them need lifelong medication It can be seen that the domestic insulin market has great market space and growth potential in the future The industry forecasts that China's insulin market capacity will only account for 20% of the global market capacity by 2030, when the domestic insulin market capacity will be nearly 12 billion US dollars.