Drafting of the national standard for the pharmaceutical cold chain, Speed Global offers suggestions and suggestions

On August 21, the national standard kick-off meeting of the "Pharmaceutical Cold Chain Logistics Operation Specification" led by the China Medical Logistics Branch was successfully held in Nanjing. According to the requirements of the National Standardization Management Committee, it is planned to complete suggestions and suggestions in 2020

Drafting units such as China IOT Pharmaceutical Logistics Branch, Speed Global, Livzon Pharmaceutical, Sinopharm, Shanghai Pharmaceuticals, China Resources, etc. participated in this meeting. The meeting was chaired by Guo Wei, Director-General of the Pharmaceutical Logistics Standardization Working Group of the National Logistics Standardization Technical Committee and Executive Deputy Secretary-General of the Pharmaceutical Logistics Branch of China Federation of Logistics and Purchasing.

Yu Songhai

Chairman of Speed Global Group

      Qin Yuming, the executive deputy leader of the Pharmaceutical Logistics Standardization Working Group of the National Logistics Standardization Technical Committee and the executive vice chairman of the Pharmaceutical Logistics Branch of the China Federation of Logistics and Purchasing, first expressed welcome and thanks to the attending representatives, and then emphasized the revision of the national standard. Importance. After 5 years of vigorous promotion, the old version of the national standard has made significant progress in the operation of the drug cold chain throughout China. This national standard has not only been recognized by industry companies, but also by the national and local bureaus. .

With the issuance of the "Vaccine Management Law", there are content in the standards that are inconsistent with the regulations, such as temperature record retention time limit requirements, etc., which will be improved in the later revision process.

Chairman Yu Songhai made suggestions for the national standard and proposed the following amendments:

(A) It should be added: if the receiving area is not in the cold storage, it should be transported in a refrigerated (heat preservation) box to ensure that the temperature of the medicine is always controlled within the specified temperature range.

Reason: The current situation in China is that except for a few large pharmaceutical distribution companies, most consignees do not have compliant cold storage facilities, such as hospitals, clinics, laboratories, and individuals. Some places are in downtown areas, small places, or The passage of trucks is restricted. In this case, only refrigerated trucks are used for transportation, and the whole temperature control cannot be achieved. The more mobile and more flexible refrigerated (insulation) box transportation can actually achieve the whole temperature control of the medicine.

(B) The refrigeration (heat preservation) box and the supporting cold storage agent shall meet the configuration requirements of the refrigerated medicine temperature and transportation timeliness, and the temperature detection and recording equipment or materials shall be attached with the goods. The heat preservation time of the refrigeration (heat preservation) box to maintain the reasonable storage temperature of the medicine should not be less than 48 hours under various seasonal conditions.

Reason: If the incubator only considers the temperature and does not consider the transportation timeliness, it will cause the possibility of over-temperature. In our country, the region is vast and the climate is complex. At the same time, because the transportation of medicines involves road transportation, air transportation, railway transportation and other complex conditions, the longest The transportation time may exceed one week, and certain requirements must be made for the heat preservation time of the incubator, otherwise there will be a greater risk to the quality of the medicine during the transportation process!

(C) Can it be increased: During the transportation of refrigerated trucks, it is not allowed to change the truck midway without reason, and it is not allowed to load medicines and food in the same truck.

Reason: At present, there are two situations in the transportation of medicines by refrigerated trucks: LTL and special vehicle transportation. The special vehicle transportation is relatively standardized, because the temperature control can be monitored throughout the whole process from the origin to the destination, and there will be no excessive loading and unloading in the middle; but LTL In cold chain transportation, food and medicine are often mixed together, and the optimal cost is achieved through the assembly behavior of branch and trunk vehicles. During the operation, it is almost impossible to keep the medicine temperature constant. This is exactly what our new GSP standard focuses on solving.

(D) It should be added: When the monitored temperature value exceeds the specified range when the drug is stored in the cold storage and transported in the refrigerated truck, the recording interval shall not exceed 2Min each time,..........

Reason: Because in the process of air transportation, the transmission of movement signals is not allowed in the first place, so it is impossible to give an audible and visual alarm and send out an alarm message. Therefore, in order to be rigorous here, it should be limited. In the international drug cold chain transportation, air transportation is basically the main one, and there is no way to provide real-time audible and visual alarms.

(E) It is recommended to remove "in transit": the refrigerated trucks and refrigerated (heat preservation) boxes in use should be subjected to in-transit temperature verification under extreme temperature conditions every year.

Reason: The temperature verification in transit caused a great waste. It is unreasonable for a large number of refrigerated trucks to run on each business line for verification, and it takes a lot of time and expense. The same is true for refrigerated containers. Transportation of tens of thousands of boxes for the purpose of verifying twice a year is a waste of resources.

F Economical method for verification.

(G) Increase the explanation of extreme temperature environmental conditions: For example: the highest temperature is minus 40 degrees Celsius and the lowest temperature is minus 10 degrees Celsius.

Reason: According to actual tests, the outdoor temperature in East China and South China in summer is 37-38 degrees Celsius, the temperature in the enclosed truck compartment can reach above 60 degrees Celsius, and the minimum temperature in winter in Northeast China can reach below -30 degrees Celsius. According to the principle of fairness, it should be set A national standard, otherwise there will be a huge gap in extreme temperature and environmental conditions, and a large gray space will be formed.

(H) It is recommended to delete: Quality management personnel should have a junior college degree or above in pharmacy, or a college degree or above in relevant majors such as medicine, biology, chemistry, or a professional technical title of pharmacy or above.

Reasons: The evaluation of talents should not be based on academic qualifications or majors alone, and this position should be "quality management", not drug research and development or manufacturing. More attention should be paid to the ability and experience of "quality management". The evaluation and limitation of talents in national standards is not in line with the spirit of reform, opening up and scientific development.

(I) It is recommended to increase the requirements for software facilities, such as "transportation process management system" as a necessary condition

(J) Suggested additions: When transporting medicines in refrigerated trucks, the cooler must not be turned off in the middle. When transporting in summer, refrigerated (heat preservation) boxes must be used for packaging when loading and unloading during transportation for more than 15 minutes.

These suggestions are only the words of the Speed Global family, and there may be many imperfect considerations. Here, they are just for introduction. I hope that more experts can put forward constructive opinions to contribute to the standardization and standardization of China's pharmaceutical cold chain, and at the same time for protection. Do your part in the lives and health of the people! "