Article 1 In order to strengthen the management of vaccine storage and transportation, to ensure the quality of vaccines, and to safeguard the safety and efficacy of preventive inoculation, this specification is formulated in accordance with the "Regulations on the Administration of Vaccine Circulation and Preventive Vaccination" (hereinafter referred to as the Regulations).
Second Article This specification applies to the management of vaccine storage and transportation process as stipulated in the regulations.
Article 3 The disease prevention and control institutions, vaccine manufacturers, vaccine wholesale enterprises should have professional and technical personnel engaged in vaccine management, vaccination units should have full-time (part-time) personnel responsible for vaccine management. Disease prevention and control institutions, vaccination units, vaccine manufacturers, vaccine wholesalers should be equipped with storage and transportation facilities and equipment to ensure the quality of vaccines, the establishment of vaccine storage and transportation management system, and do a good job in the storage and transportation of vaccines.
Article IV The 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 these norms.
Article V Vaccine manufacturers, vaccine wholesalers in the sale of vaccines, in addition to providing documents in accordance with the provisions of Article 17 of the regulations, at the same time, should provide vaccine transportation equipment, time, temperature records and other information. Disease prevention and control agencies in the supply or distribution of vaccines, shall provide the vaccine transportation equipment, time, temperature records and other information.
Article 6 The disease prevention and control institutions, vaccination units, vaccine wholesale enterprises in the receipt or purchase of vaccines, shall request and check the vaccine manufacturers, vaccine wholesale enterprises to provide the documents and information specified in Article 5. Receiving should verify the vaccine transportation equipment, time, temperature records and other information, and the vaccine variety, dosage form, approval number, quantity, specifications, batch number, expiration date, supply units, manufacturers and other contents of the acceptance, make a record. Vaccines that meet the requirements can only be received.
Article VII of the disease prevention and control institutions, vaccination units, vaccine wholesalers on the acceptance of vaccines, should be stored in accordance with its temperature requirements in the appropriate refrigeration facilities and equipment, and according to the vaccine varieties, batch number classified code.
Article 8 The disease prevention and control institutions, vaccination units, vaccine manufacturers, vaccine wholesalers shall sell, supply or distribute vaccines in accordance with the principle of first-in-first-out, first-in-first-out, and first-in-nearest-validity.
Article 9 Vaccine manufacturers, vaccine wholesale enterprises shall regularly inspect and record the stored vaccines. Found that the quality of abnormal or exceed the expiration date, etc., should be taken in a timely manner, isolation, suspension of shipments and other measures, and promptly report the location of the food and drug supervision and management department to deal with; received the report of the food and drug supervision and management department shall be the quality of abnormal or expired vaccines to take appropriate measures in accordance with the law.
Article 10 of the disease prevention and control institutions, vaccination units shall regularly check the stored vaccines and records, found abnormal quality of the vaccine, shall immediately stop the supply, distribution and vaccination, and promptly report to the county-level health administrative departments and food and drug supervision and management departments at the location shall not be dealt with on their own. Received the report of the health administrative department shall promptly organize disease prevention and control institutions and vaccination units to take the necessary emergency measures, and at the same time to report to the higher administrative department of health; received the report of the food and drug supervision and management department shall take appropriate measures according to law on the quality of abnormal vaccines.
Article XI of disease prevention and control institutions, vaccination units stored due to natural disasters and other causes of vaccines expired, expired, in accordance with the provisions of the "Regulations on the Management of Medical Waste" for centralized disposal.
Article XII of the vaccine manufacturers, vaccine wholesalers shall designate a person in charge of vaccine delivery, boxing, shipping work. Before shipment should check the start-up and operation of refrigerated transportation equipment to meet the prescribed requirements before shipment.
Article XIII of the disease prevention and control institutions, vaccine manufacturers, vaccine wholesalers use refrigerated trucks or vaccine carriers equipped with refrigeration equipment during transportation, the temperature conditions should be consistent with the vaccine storage requirements.
Article XIV of the receipt of vaccines, acceptance, in-store inspection records should be kept until more than 2 years beyond the expiration date of the vaccine for inspection.
Article XV of the disease prevention and control institutions, vaccination units, vaccine manufacturers, vaccine wholesalers must be in accordance with the "Chinese People's *** and the National Pharmacopoeia" (current version), "Code of Practice for Preventive Vaccination" and other relevant vaccine storage, transportation temperature requirements
Vaccine Storage and Transportation of Electronic Thermometers
Vaccine Storage and Transportation of Electronic Thermometers
Requirements for the storage and transportation of vaccines. For vaccines not included in the pharmacopoeia, storage and transportation in accordance with the instructions for use of vaccines.
Article 16 The disease prevention and control institutions, vaccination units, vaccine manufacturers, vaccine wholesale enterprises shall monitor and record the temperature of stored vaccines in accordance with the following requirements.
(a) Automatic temperature recorders shall be used to record the temperature of ordinary cold storage and low-temperature cold storage.
(ii) Thermometers shall be used to monitor the temperature of refrigerators (including ordinary refrigerators, ice-lined refrigerators and cryogenic refrigerators). Thermometers should be placed in the middle of the refrigerator and freezer in ordinary refrigerators, at the bottom and near the top of ice-lined refrigerators, and in the middle of low-temperature refrigerators. Temperature recordings are made once a day in the morning and once in the afternoon.
(c) When the temperature of the cold storage facilities and equipment exceeds the requirements for the storage of vaccines, corresponding measures should be taken and recorded.
Article XVII of the disease prevention and control institutions, vaccine manufacturers, vaccine wholesalers should be transported during the vaccine temperature monitoring and recording. Records include the name of the vaccine, the manufacturer, supply (sending) unit, quantity, batch number and expiration date, departure and arrival time, departure and arrival of the vaccine storage temperature and ambient temperature, temperature changes during transportation, the name of the means of transportation and pick-up and drop-off of vaccine personnel signature.
Article 18 Provincial disease prevention and control institutions, vaccine manufacturers, vaccine wholesalers shall have facilities and equipment to meet the requirements of vaccine storage and transportation temperature:
(a) cold storage for vaccine storage, its volume should be compatible with the scale of production, operation, and use;
(b) Cold storage should be equipped with automatic monitoring, regulation, display, recording temperature conditions and alarm equipment, backup generator or other equipment. Alarm equipment, standby generator sets or the installation of dual circuit, standby refrigeration unit;
(c) refrigerated trucks for vaccine transportation;
(d) refrigerated trucks should be able to automatically regulate, display and record the temperature condition.
Article 19 The municipal and county-level disease prevention and control institutions in the district shall have facilities and equipment that meet the requirements for vaccine storage and transportation temperature:
(1) cold storage or refrigerator dedicated to the storage of vaccines, and its volume should be compatible with the size of the use;
(2) the cold storage should be equipped with equipment to automatically monitor, regulate, display, and record the temperature conditions as well as alarms, standby Generator sets or install dual circuit, standby refrigeration unit;
(iii) Refrigerated trucks used for vaccine transportation or vehicles equipped with refrigeration equipment;
(iv) Refrigerated trucks should be able to automatically regulate, display and record the temperature condition.
Article 20 Preventive health care services at the village level shall be equipped with refrigerators for storing vaccines, and use refrigerated containers (packages) equipped with ice rafts for transporting vaccines. They shall also be equipped with enough ice rows for village-level vaccination units to use when receiving vaccines.
Article 21: Vaccination units shall have refrigerators or use refrigerated boxes (packages) equipped with ice rafts to store vaccines.
Article 22 of the disease prevention and control institutions, vaccine manufacturers, vaccine wholesalers should be dedicated to the vaccine storage, transportation facilities and equipment management and maintenance. Vaccination units should be maintained vaccine storage equipment.
Article 23 of the disease prevention and control institutions, vaccination units, vaccine manufacturers, vaccine wholesalers should establish and improve the vaccine storage and transportation facilities and equipment files, and vaccine storage, transportation facilities and equipment to record the operating conditions.