The two ministries released the 2017 version of the vaccine storage and transportation management practices

Pharmaceutical Network December 29 hearing

Health and Family Planning Commission of each province, autonomous region and municipality directly under the Central Government, Food and Drug Administration, Xinjiang Production and Construction Corps Health Bureau, Food and Drug Administration, China Center for Disease Control and Prevention:

In order to strengthen the administration of vaccine storage and transportation, according to the revised Regulation on the Circulation and Vaccination of Vaccines and the Opinions on Further Strengthening the Management of Vaccine Circulation and Vaccination (Guo Ban Fa [2017] No. 5), the national health The Family Planning Commission and the State Food and Drug Administration have also revised the "Code of Practice for the Storage and Transportation of Vaccines (2006) 104") to form the "Code of Practice for the Storage and Transportation of Vaccines (2017 Edition)" (available from National Health Administration Family Planning Commission website to download.) Now issued to you, please follow the implementation.

National Health and Family Planning Commission Food and Drug Administration

December 15, 2017

Article 1 This Regulation is formulated to regulate the storage and transportation of vaccines, to strengthen the quality control of vaccines and to ensure the safety and effectiveness of vaccination. According to the Regulation on Circulation and Vaccination of Vaccines, this Regulation is formulated.

Article 2 This Code is applicable to the vaccine storage and transportation management of disease prevention and control institutions, vaccination units, vaccine manufacturers, vaccine distribution enterprises and vaccine storage enterprises. Disease prevention and control institutions, vaccine storage and transportation management of vaccination units shall also comply with the " Vaccination work norms "; Vaccine manufacturers, vaccine distribution companies, vaccine storage business vaccine storage, transport management should also abide by the" quality management standards for pharmaceuticals. "

Article 3 Vaccine manufacturing enterprises, vaccine distribution enterprises and vaccine storage enterprises shall be equipped with full-time personnel engaged in vaccine management and disease prevention and control institutions. Vaccination units shall be accompanied by specialized (and) personnel responsible for vaccine management and shall receive relevant business training. Control institutions, vaccination units, vaccine manufacturers, vaccine distribution companies and vaccine storage enterprises shall establish vaccine storage and transportation management systems and do well in the storage and transportation of vaccines.

Article 4 The health and family planning administrative departments at all levels and the food and drug supervision and administration department shall be responsible for the supervision and administration of the implementation of this code.

Article 5 Disease prevention and control agencies, inoculation units, vaccine manufacturers, vaccine distribution enterprises and vaccine storage enterprises shall be equipped with equipment for the storage and transportation of cold chain facilities to ensure the quality of vaccines.

(1) Provincial disease prevention and control agencies, vaccine manufacturers, vaccine distribution enterprises and vaccine storage enterprises shall be equipped with ordinary cold storage, cold storage, refrigerated trucks and automatic temperature monitoring equipment or equipment according to the needs of vaccine storage and transportation.

(2) The municipal, county-level disease prevention and control institutions with districts shall be equipped with general refrigerators, refrigerated trucks or vaccine transport vehicles, low-temperature refrigerators, ordinary refrigerators, freezers (bags), ice chillers and temperature monitoring equipment or equipment.

(C) vaccination units should be equipped with ordinary refrigerators, freezers (bags), ice and temperature monitoring equipment or equipment.

Article 6 Disease prevention and control agencies, vaccination unit Vaccine storage, transport facilities and equipment management and maintenance requirements:

(A) The cold storage volume used for vaccine storage should be compatible with the storage requirements, and should be provided with equipment for automatically monitoring, regulating, displaying and recording the temperature conditions and alarms, standby refrigeration units, standby generators or installing dual circuits.

(B) refrigerated trucks can automatically regulate, display and record the temperature conditions.

(C) refrigerator, update should be selected medical instruments Registration card medical refrigerator.

(D) refrigerated trucks, refrigerators, freezers (bags) in the storage, transport vaccine should reach the appropriate temperature requirements.

(E) automatic temperature monitoring equipment, temperature measurement accuracy requirements within ± 0.5 ℃; refrigerator monitoring thermometer, temperature measurement accuracy requirements within ± 1 ℃.

Article 7 The conditions of the region or unit should establish an automatic temperature monitoring system.Technical parameters of the automatic temperature monitoring system measuring range, accuracy, error and so on to meet the vaccine storage, transportation management needs, with continuous monitoring, continuous recording, data storage, Display and alarm function.

Article VIII of disease prevention and control agencies, vaccination units, vaccine production enterprise , Vaccine distribution companies, vaccine storage enterprises should establish and improve the file of cold chain equipment, and vaccine storage, transport facilities and equipment operating conditions were recorded.

Article 9 The CDC shall regularly evaluate the equipment and operation status of cold chain facilities and equipment in its jurisdiction and make plans to supplement and update the cold chain equipment according to the needs of vaccination work. Refer to the Reference Standard for Cold Chain Equipment Maintenance Period and Service Life '(Annex 1), reported to the same level health planning and administrative departments and superior disease prevention and control agencies, timely replenishment, updating of cold chain equipment and facilities.

Article 10 Disease prevention and control agencies, inoculation units, vaccine manufacturers, vaccine distribution companies and vaccine storage enterprises must store and deliver vaccines according to the vaccine instruction manual and the "Code of Practice for Vaccination" and other relevant vaccine storage and transportation requirements.

Article 11 Disease prevention and control agencies and inoculation units shall monitor and record the storage temperature of vaccines according to the following requirements.

(1) The automatic temperature monitoring equipment or equipment is used to monitor the cold storage temperature. At least one manual temperature record shall be made at the same time every morning and afternoon (interval is not less than 6 hours). Fill in the 'cold chain equipment temperature record' (Annex 2 ).

(2) Temperature monitoring of refrigerators (including ordinary refrigerators and low temperature refrigerators) by using thermometers shall be carried out daily and in the afternoon at intervals of not less than 6 hours. Fill in the temperature record of cold chain equipment (Annex 2 ) Thermometers should be placed in the middle of ordinary refrigerator freezer and freezer, the middle of the low temperature refrigerator.Each time should be measured in the refrigerator to store the vaccine room temperature, refrigerator freezer temperature should be controlled at 2 ℃ ~ 8 ℃, Freezer temperature should be controlled at ≤ -15 ℃. Conditional areas or units can be used automatic temperature monitoring equipment or equipment for temperature monitoring of the refrigerator records.

(C) thermometers can be used to monitor the temperature of the freezer (package), the conditions of the region or unit can use the external display temperature function of the refrigerator (bag).

Article 12 Vaccine delivery companies, disease prevention and control agencies, and vaccination agencies shall monitor the temperature of the vaccine during transportation and fill in the 'Record of vaccine transport temperature' (Annex 3).

(A record of the vaccine transport, vaccination methods, vaccine name, manufacturer, specifications, lot number, period of validity, quantity, use, departure and arrival time, departure and arrival of the vaccine storage temperature and ambient temperature, Mileage, send / receive vaccine units, send / receive Vaccine Man signature.

(B) transport time of more than 6 hours, to be recorded on the way the temperature on the way the temperature record interval of not more than 6 hours.

Article 13 For long-term cold-chain transportation, vaccines are required to be delivered to remote areas. Provincial CDCs should put forward the requirements of the vaccine manufacturers to affix a temperature control label and at Bidding Document proposed vaccine manufacturers should be based on the stability of the vaccine selection of the appropriate temperature control labels.

Article 14 The temperature record during the storage and transportation of the vaccine may be paper or electronic format that can be read. The temperature record shall be kept for more than 2 years after the vaccine is valid for future reference.

Article 15 Vaccine manufacturing enterprises, vaccine distribution enterprises and disease prevention and control institutions shall, when supplying or distributing vaccines, provide the receiving party with the type of equipment for the transport of the vaccine, the time of departure and arrival, the temperature record of the transport of the vaccine during the transportation, Invoice and receipt and other information.

Article 16 When disease prevention and control institutions or vaccination units receive or purchase vaccines, they should obtain and inspect photocopies of the "Certificate of Issue of Biological Products Approval Certificate" provided by vaccine manufacturers or vaccine distribution enterprises, and import vaccines shall also provide "Import Drug customs clearance, "a copy of the receipt should verify the type of vaccine transport equipment, the transport of vaccine during transport temperature records, the vaccine transport, vaccine refrigeration, vaccine name, manufacturer, specifications, lot number, expiry date, quantity , Uses, departure and arrival times, vaccine storage temperature and ambient temperature at departure and arrival, etc., to be verified and documented.

(A) for the information is complete, in line with the requirements of the temperature of cold chain vaccine, before receiving.

(B) of the vaccine is not complete, in line with the cold chain transport temperature requirements of the vaccine, the receiving unit can temporarily save the vaccine to be additional information, meet the first paragraph for the receipt of storage procedures.

(C) of the vaccine can not provide the transport process of recording the temperature or cold chain transport does not meet the temperature requirements of the vaccine shall not receive or purchase vaccine storage, transport temperature anomalies in the treatment, in accordance with the twenty-second, two Thirteen, twenty-four implementation.

Article XVII disease prevention and control agencies, vaccination units of qualified vaccines should be stored in accordance with the requirements of the temperature requirements, according to the vaccine species, batch number code release.

Article 18 Disease prevention and control agencies and vaccination units shall supply, distribute and use vaccines according to the expiration date or the order of purchase.

Article 19 Vaccine manufacturing enterprises, vaccine distribution enterprises and vaccine storage enterprises shall regularly check and record the stored vaccines, and take measures such as isolation and storage and suspension of shipment for any vaccine that exceeds the expiration date or the storage temperature does not meet the requirements.

Article 20 Disease prevention and control agencies and inoculation units shall regularly check and record the stored vaccines. Vaccines that are unidentifiable, in excess of the expiration date, and that do not meet the storage temperature requirements should be reported regularly, with the first type of vaccine being reported To the provincial disease prevention and control agencies, the second type of vaccine reported to the county disease prevention and control agencies.

Vaccines to be scrapped shall be uniformly destroyed in accordance with the relevant provisions under the supervision of the local food and drug supervision and administration departments and the health and family planning administrative departments Vaccines to be scrapped by vaccination units shall be uniformly collected and rehoused to the county disease prevention and control institutions for unified destruction. Prevention and control agencies, vaccination units should truthfully record the destruction, recovery, destruction records for more than 5 years.

Twenty-one vaccine receipt, inspection, records in the library inspection and other records should be kept beyond the validity of the vaccine for 2 years for future reference.

Article 22 Vaccines should be stored and transported within the approved temperature range (control temperature) .Vehicle manufacturers should assess the impact of temperature deviations caused by routine operations such as storage and storage of vaccines, handling during transport, on vaccine quality, and Receiving conditions. Meet the receiving conditions, the vaccine distribution companies, disease prevention and control agencies, vaccination units should receive the vaccine.

Article 23 Where disease prevention and control agencies and vaccination units adopt refrigerators and freezers (bags) to store vaccines, they should switch refrigerators and freezers (bags) in time to minimize the vaccine exposure when storing and using vaccines Outside the control temperature range.

Article 24 In exceptional circumstances, such as power failure, storage and transportation equipment failure, resulting in abnormal temperature, to be filled in 'vaccine storage and transport abnormal temperature record table' (Annex 4). Vaccine manufacturers should promptly start a major deviation Or secondary deviation process, to assess its right product quality Of the potential impact, and the assessment report submitted to the appropriate unit.After assessment of the quality of the product has no effect, can continue to use.After the assessment of the adverse impact on product quality, should be in the local health and family planning administrative departments and food drug Surveillance under the supervision of the destruction.

The twenty-fifth article of this standard by the National Health and Family Planning Commission and the State Food and Drug Administration responsible for the interpretation.

The twenty-sixth article of this standard since the date of promulgation.