Article 1 In order to strengthen the management of vaccine storage and transportation, ensure the quality of vaccines and ensure the safety and effectiveness of vaccination, this Regulation is formulated in accordance with the Regulations on the Administration of Vaccine Circulation and Vaccination (hereinafter referred to as the Regulations).

Article 2 This Code is applicable to the management of vaccine storage and transportation as stipulated in the Regulations.

Article 3 Disease prevention and control institutions, vaccine production enterprises and vaccine wholesale enterprises shall have professional and technical personnel engaged in vaccine management, and vaccination units shall have full-time (part-time) personnel responsible for vaccine management. Disease prevention and control institutions, vaccination units, vaccine production enterprises and vaccine wholesale enterprises should be equipped with storage and transportation facilities and equipment to ensure the quality of vaccines, establish a management system for vaccine storage and transportation, and do a good job in vaccine storage and transportation.

Fourth health administrative departments at all levels and food and drug supervision and management departments are responsible for the supervision and management of the implementation of this specification.

Article 5 When selling vaccines, vaccine production enterprises and vaccine wholesale enterprises shall not only provide the documents specified in Article 17 of the Regulations, but also provide information such as equipment, time and temperature records of vaccine transportation. When supplying or distributing vaccines, disease prevention and control institutions shall provide information such as equipment, time and temperature records of vaccine transportation.

Article 6 Disease prevention and control institutions, inoculation entities and vaccine wholesale enterprises shall, when receiving or purchasing vaccines, ask for and check the certification documents and materials provided by vaccine production enterprises and vaccine wholesale enterprises specified in Article 5. When receiving the goods, the equipment, time and temperature records of vaccine transportation should be verified, and the variety, dosage form, approval number, quantity, specification, batch number, validity period, supplier and manufacturer of the vaccine should be accepted and recorded. Only vaccines that meet the requirements can be accepted.

Article 7 Disease prevention and control institutions, inoculation entities and vaccine wholesale enterprises shall store qualified vaccines in corresponding cold storage facilities and equipment according to their temperature requirements, and release them according to vaccine varieties and batch numbers.

Article 8 Disease prevention and control institutions, inoculation entities, vaccine production enterprises and vaccine wholesale enterprises shall sell, supply or distribute vaccines according to the principles of first production, first output, first in first out and first out in the near future.

Ninth vaccine production enterprises and vaccine wholesale enterprises should regularly check and record the stored vaccines. If the quality is abnormal or exceeds the validity period, measures such as isolation and suspension of delivery shall be taken in time, and the local food and drug supervision and administration department shall be reported in time for handling; The food and drug supervision and administration department that receives the report shall take corresponding measures according to law for vaccines with abnormal or expired quality.

Tenth disease prevention and control institutions and vaccination units shall regularly check and record the stored vaccines. If the vaccine with abnormal quality is found, it shall immediately stop the supply, distribution and inoculation, and report to the local county-level health administrative department and food and drug supervision and management department in time, and shall not handle it by itself. The health administrative department that receives the report shall promptly organize the disease prevention and control institutions and vaccination units to take necessary emergency measures and report to the health administrative department at the next higher level; The food and drug supervision and administration department that receives the report shall take corresponding measures according to law for vaccines with abnormal quality.

Eleventh disease prevention and control institutions, vaccination units stored vaccines due to natural disasters and other reasons caused by expiration, failure, in accordance with the provisions of the "Regulations" on the management of medical waste for centralized disposal.

Twelfth vaccine production enterprises and vaccine wholesale enterprises shall designate special persons to be responsible for the transportation, packaging and distribution of vaccines. Before shipment, check the start-up and operation of refrigerated transport equipment, and then shipment can be carried out only after it meets the specified requirements.

Thirteenth disease prevention and control institutions, vaccine production enterprises and vaccine wholesale enterprises use refrigerated trucks or vaccine transport vehicles equipped with refrigerated equipment during transportation, and their temperature conditions shall meet the requirements of vaccine storage.

Fourteenth vaccine receipt, acceptance, inspection in the warehouse and other records should be kept for more than 2 years for future reference.

Fifteenth disease prevention and control institutions, vaccination units, vaccine production enterprises, vaccine wholesale enterprises must be in accordance with the "China Pharmacopoeia" (current edition), "vaccination work norms" and other relevant vaccine storage and transportation temperature.

Electronic thermometer for vaccine storage and transportation

Electronic thermometer for vaccine storage and transportation

Q: Do a good job in the storage and transportation of vaccines. Vaccines that are not included in the Pharmacopoeia shall be stored and transported according to the instructions for vaccine use.

Sixteenth disease prevention and control institutions, vaccination units, vaccine production enterprises and vaccine wholesale enterprises shall monitor and record the temperature of stored vaccines in accordance with the following requirements.

(a) should use automatic temperature recorder to record the temperature of ordinary cold storage and low temperature cold storage.

(2) Thermometers should be used to monitor the temperature of refrigerators (including ordinary refrigerators, ice-lined refrigerators and low-temperature refrigerators). Thermometers should be placed in the middle of the cold storage room and freezing room of ordinary refrigerators, near the bottom and top cover of ice-lined refrigerators, and in the middle of low-temperature refrigerators. Record the temperature once every morning and once every afternoon.

(three) when the temperature of cold storage facilities exceeds the requirements of vaccine storage, corresponding measures should be taken and recorded.

Seventeenth disease prevention and control institutions, vaccine production enterprises and vaccine wholesale enterprises should monitor and record the temperature during the transportation of vaccines. Records include vaccine name, manufacturer, supplier (sender), quantity, batch number and expiration date, departure and arrival time, storage temperature and ambient temperature of the vaccine at departure and arrival, temperature change during transportation, name of transport vehicle, signature of personnel who pick up and drop off the vaccine, etc.

Eighteenth provincial disease prevention and control institutions, vaccine production enterprises and vaccine wholesale enterprises should have facilities and equipment that meet the requirements of vaccine storage and transportation temperature:

(a) the cold storage for storing vaccines, the volume of which should be commensurate with the scale of production, operation and use;

(two) cold storage should be equipped with automatic monitoring, control, display, recording temperature and alarm equipment, installation of standby generator set or two-way circuit, standby refrigeration unit;

(3) refrigerated trucks used for vaccine transportation;

(four) refrigerated trucks should be able to automatically control, display and record the temperature.

Nineteenth municipal and county-level disease prevention and control institutions with districts shall have facilities and equipment that meet the requirements of vaccine storage and transportation temperature:

(1) The volume of the cold storage or refrigerator specially used for storing vaccines shall be commensurate with the scale of use;

(two) cold storage should be equipped with automatic monitoring, control, display, recording temperature and alarm equipment, installation of standby generator set or two-way circuit, standby refrigeration unit;

(3) Refrigerated trucks used for vaccine transportation or vehicles equipped with refrigeration equipment;

(four) refrigerated trucks should be able to automatically control, display and record the temperature.

Twentieth township preventive health care service institutions should be equipped with refrigerators to store vaccines, and use refrigerated boxes (bags) equipped with ice rows to transport vaccines. And equipped with enough ice rafts for village vaccination units to use when receiving vaccines.

Twenty-first vaccination units should have refrigerators or use vaccine refrigerators (bags) equipped with ice rafts to store vaccines.

Twenty-second disease prevention and control institutions, vaccine production enterprises and vaccine wholesale enterprises should have special personnel to manage and maintain vaccine storage and transportation facilities and equipment. The inoculation entity shall maintain the vaccine storage equipment.

Twenty-third disease prevention and control institutions, vaccination units, vaccine production enterprises and vaccine wholesale enterprises shall establish and improve the archives of vaccine storage and transportation facilities and equipment, and record the operation status of vaccine storage and transportation facilities and equipment.