What should be considered in the transformation of production line of pharmaceutical enterprises?

[market analysis of chinapharma.com] recently, a pharmaceutical company announced that the company needs to carry out technical transformation on the freeze-dried powder injection production line in the preparation workshop, so it plans to suspend production for about one month The pharmaceutical company said that the transformation of the preparation production line was carried out according to the plan, and the production of the preparation workshop will be arranged reasonably, which will not affect the production of the preparation in 2019 After the completion of this transformation, the company's preparation production line will have the conditions to produce various specifications of freeze-dried powder injection products, providing support for the pilot test of new products and the production of some approved products I learned that since the start of the new year, many pharmaceutical companies have plans to transform their production lines Some insiders said that the transformation of production line is conducive to promoting production and improving product quality, but at the same time, there are corresponding risks in the transformation First, technology risk Pharmaceutical enterprises are bound to face many risks in the process of production line transformation, among which the key is technology risk   For example, in order to adapt to the increasing national drug standards, in September 2017, some pharmaceutical companies encountered bottlenecks due to the technical transformation of the production line, which is expected to be unable to solve in a short period of time The company's annual revenue of tens of millions of drugs suspended production after the expiration of the entrusted production approval document, which led to the company's inability to supply the drug to the market in a short period of time, which may cause the company's performance to appear significantly Slide downward Second, supply risk Under the influence of environmental protection policies such as environmental tax, many small and medium-sized API enterprises stop production or close down due to unqualified environmental protection indicators In addition, the number of API manufacturers is already large Under the background of environmental protection, high pressure and limited approval, there are only two or three API manufacturers left Once encountering the factors such as production line transformation and cost increase, it is easy to cause API shortage and drug shortage For example, in November 2018, many children's drug products used to prevent and treat vitamin A and D deficiency were out of stock and in short supply, which caused the price of products to rise Some manufacturers responded that the supply was insufficient due to the upgrading of the company's production line and equipment commissioning, and believed that the supply would be restored soon after the completion of the transformation of the production line For another example, on January 8, 2019, the centralized purchase service center of pharmaceutical devices in Inner Mongolia Autonomous Region issued a notice that from May 1, 2018 to December 31, 2018, 108 pharmaceutical applications were withdrawn from the Internet and a letter of commitment for unified non supply was submitted According to the notice, the reasons for the suspension of drugs are the rise of raw materials, the transformation of production lines, environmental pollution and other reasons On November 7, 2018, Liaoning pharmaceutical procurement center issued the No 3 drug shortage warning forecast in 2018, in which 15 pharmaceutical enterprises were short of capacity due to raw materials, production line transformation and other reasons To sum up, it is not uncommon that the transformation of production lines of pharmaceutical enterprises leads to drug shortage or even production suspension Third, the transformation cost of the production line often makes the enterprise miserable It is understood that compared with the old version of GMP, the new version has greatly improved the production hardware and software standards of production enterprises, and is a new production standard in line with international standards The industry has calculated that according to the current version of GMP standard, the cost of building a new production line is equivalent to the total profit of a medium-sized pharmaceutical enterprise throughout the year It can be seen that the transformation cost of the production line and the risk of investment are very large This also requires pharmaceutical enterprises to do a good job in risk prevention and detailed planning before transformation to ensure the success of transformation According to the industry, in fact, with the promotion of the new GMP and the demand for the transformation of new and old kinetic energy under the high pressure of environmental protection, the transformation of production lines has become a problem that pharmaceutical enterprises have to consider in their development.