Nanjing's three "temperature locks" online and offline for the vaccine to ensure the safety of vaccine at high temperature

As a biological product, vaccines are more sensitive to temperature, and excessive temperature or too low will affect it. With the continuous rise in temperatures in the near future, vaccines with strict requirements for storage and transportation temperatures are facing high -temperature "baking" tests. To this end, the market supervision department of Nanjing has adopted the method of "online real -time monitoring+regular inspection of offline" to ensure the safety of summer vaccine.

It is understood that the "Vaccine Management Law of the People's Republic of China" clearly requires that the vaccine should be in the prescribed temperature environment during the storage and transportation process, and the cold chain storage and transportation should meet the requirements. At present, the majority of the storage temperature in my country is 2 ° C to 8 ° C (such as the new crown virus vaccine). In this constant low -temperature environment, it can ensure the quality and activity of the vaccine. Therefore, the storage and storage temperature of the vaccine directly affects whether the vaccination is safe and effective, which is related to the health and life safety of the general public.

Recently, the market supervision department of Nanjing has adopted the method of "online real -time monitoring+regular inspection of offline" to ensure the safety of summer vaccine.

First of all, the three "temperature locks" are required to set the vaccine: the first weight, the staff of the vaccine storage and vaccination units regularly check the internal temperature displayed by the medical refrigerator of the vaccine. The second is that the staff of the vaccine storage and vaccination units placed the temperature meter in each refrigerator, and performed at least once a day and afternoon at least once each (no less than 6 hours). Fill in the "cold chain equipment temperature record form" Essence Third, install the temperature probe for 24 hours of work in each medical refrigerator, and upload the monitored data to the comprehensive service management information system in Jiangsu Province in real time. The system will immediately send early warning information to the refrigerator manager. After receiving the early warning information, the staff will immediately take corresponding emergency treatment measures.

Online, the city and district market supervision departments have fully enabled the "Nanjing Pharmaceuticals Management Supervision System" to achieve standardized online operations. First, through the mobile law enforcement terminal, it is convenient to quickly query the number of bottoms and basic information of the supervisory objects; the second is to upload on -site inspection data and pictures in real time through the smart supervision platform; the third is to dynamically grasp the city's vaccine inspection and inspection work through the remote regulatory system.

Offline, cities and district -level regulators check on the spot to check the vaccination points, related management systems and equipment file materials, check the vaccine's full -process cold chain record, biological product approval certificate, import vaccine customs clearance form, and inspection qualification report. Determine the legality compliance of the vaccine storage and transportation link.

In the next step, the Nanjing Market Supervision Bureau will take more targeted measures to effectively strengthen the quality supervision of the city's vaccine storage, transportation and prevention in the high temperature season, and implement full coverage of the disease control institutions, vaccination units, and temporary vaccination points in the area under its jurisdiction. Supervision and inspection to ensure the quality and safety of vaccines in the city. At the same time, the hidden dangers found in the supervision and inspection are strictly dealt with in accordance with laws and regulations, and a closed loop of supervision is effectively formed.

(Reporter Yin Wenjing)

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