Using pharmaceutical equipment technology to provide scientific and technological support for vaccine quality and safety

[China Pharmaceutical network industry trends] on December 23, the draft of vaccine management law was proposed for deliberation The time from the occurrence of long-term vaccine cases to the formation of the draft was less than half a year, which also reflected the importance of the state on vaccine supervision and the urgency of accelerating the improvement of the long-term mechanism of vaccine drug supervision It is reported that the draft vaccine submitted for deliberation clearly stipulates the development, production, circulation, vaccination, compensation and compensation of vaccines in the form of laws In order to reflect strict supervision, the draft proposes that the State implements a strict access system for vaccine production than for the production of general drugs (using pharmaceutical equipment technology to provide scientific and technological support for vaccine quality and safety photo source: chinapharma Com) from the above, it is not difficult to see that in the future, the vaccine industry will be in the environment of high attention from all walks of life and strict supervision by the state For the vaccine industry, a stronger security guarantee, a more complete self-examination and self-regulation system, as well as more advanced technology and pharmaceutical equipment support will be the focus of the industry's development in the future In order to help vaccine enterprises produce vaccine products with high quality and safety, pharmaceutical equipment enterprises are also making efforts According to the analysis of the insiders, one of the problems of this vaccine incident is the modification of records At present, many records of pharmaceutical enterprises are manually operated Even electronic records, there are two situations: modifiable and non modifiable, which mainly depend on the hardware design and software design In this regard, the author understands that the production of intelligent chemical plants of pharmaceutical equipment enterprises will realize automatic data recording, uploading and exclusion, and all data will be saved in the "black box", so as to eliminate the interference of artificial factors fundamentally and eliminate the possibility of similar vaccine record falsification In addition, there are also pharmaceutical equipment enterprises through technical exchanges with foreign advanced enterprises and units, to carry out technological innovation of vaccine traceability system, because in today's environment, the imperative of vaccine traceability has become a consensus in the industry In addition to production sources, storage logistics is also one of the important factors affecting vaccine quality and safety It is reported that vaccines are required to be stored and transported in the cold chain of 2 ℃ to 8 ℃ In order to avoid risks during transportation, pharmaceutical equipment enterprises have increased investment in the storage and logistics of vaccines For example, pharmaceutical equipment enterprises make full use of chip technology, so that each vaccine has its own "account", identity, temperature, geographic information, etc can be tested in real time, and form a complete information loop from output to injection If the vaccine is out of the regulatory environment, or if there is a geographical move, the chip will send out an alarm message, and the government regulatory network, enterprise network, and consumer network can find that a number of vaccine has changed Relevant personnel can start tracking according to their own authority, find out the reasons for changes in the temperature environment and geographical location of the vaccine, and then take corresponding measures For this year's highly debated vaccine event, pharmaceutical equipment personnel said that in addition to the system, the lack of technical means is actually one of the main factors that are difficult to completely solve the vaccine problem Pharmaceutical equipment enterprises can only develop and produce guaranteed vaccine products if they spare no effort to push forward the technology At present, the draft has clear responsibilities for the entire process of vaccine development, production, circulation and vaccination The draft will also implement the "four strictness" requirements, summarize the implementation experience of drug management law, vaccine circulation and vaccination management regulations, draw lessons from problem vaccine cases, draw inferences from one case to another, plug loopholes, and systematically stipulate systems, because strict Management system is an important idea of vaccine draft We believe that under the regulations of relevant systems or policies, under the shuffle of the vaccine industry, and under the improvement and improvement of pharmaceutical equipment technology, the vaccine industry can firmly hold the bottom line of quality and safety, so that the people can use safe vaccine products.