Pharmaceutical cold chain national standard drafting, Tengyiboshi stroke advice

On August 21, 2019, the launching meeting of the National Standard of Operation Specification of Pharmaceutical Cold Chain Logistics, which was revised by the Pharmaceutical Logistics Branch of China Federation of Materials, was successfully held in Nanjing. It is scheduled to be completed by 2020, according to the requirements of the Standardization Administration.

The drafting units, such as the Pharmaceutical Logistics Branch of China Federation of Materials, Tengyi Boshi, Lizon Pharmaceutical, Sinopremedy, Shanghai Pharmaceutical, China Resources, etc., participated in the meeting. The meeting was presided over by Guo Wei, Director General of the Medical Logistics Standardization Working Group of the National Technical Committee of Logistics Standardization and executive Deputy Secretary-General of the Medical Logistics Branch of China Federation of Logistics and Purchasing.

Yu Songhai

Chairman of Shanghai Tengyi Boshi International Logistics Group

Qin Yuming, executive deputy director of the Medical Logistics Standardization Working Group of the National Logistics Standardization Technical Committee and Executive Vice President of the Medical Logistics Branch of the China Federation of Logistics and Purchasing, first of all welcomed and thanked the representatives to attend the meeting, and then stressed the importance of revising this national standard. The old version of the national standard after 5 years of vigorous promotion of the whole China's drug cold chain operation level has made significant progress, this national standard has not only been recognized by the industry enterprises, but also by the national Bureau, local bureau of recognition.

With the release of the Vaccine Management Law, there are some inconsistent contents in the standard, such as the time limit requirement for temperature records, which will be improved in the later revision process.

Yu Songhai, chairman of the board, made suggestions for GB and proposed the following modification suggestions:

(a) Should be added: Where the receiving area is not in the cold storage, refrigerated (insulated) boxes should be used for transportation to ensure that the temperature of the drug is always controlled within the specified temperature range.

Reasons: The current situation in China is that, except for a few large pharmaceutical distribution companies, most of the recipients do not have compliant cold storage facilities, such as hospitals, clinics, laboratories and individuals. Some places are located in downtown areas with small areas or restricted by trucks. In this case, only refrigerated trucks are used for transportation, which cannot achieve the whole temperature control. Only when the operation is more flexible, can the transportation of cold storage (insulation) box actually achieve the whole temperature control of drugs.

(b) The cold storage (insulation) box and its accompanying cold storage agent shall meet the configuration requirements of the temperature and transportation aging of refrigerated drugs, and shall be accompanied by temperature detection and recording equipment or materials. The heat preservation aging of the cold storage box to keep the reasonable storage temperature of drugs shall not be less than 48 hours under various seasonal conditions.

Reasons: Thermal insulation box only considering the temperature and not considering the transportation prescription, will cause the possibility of overtemperature, in our country is vast in territory, complex climate, due to drug transportation involving road transportation, air transportation, railway transportation and other complex circumstances, Z long transportation time may more than one week, the thermal insulation prescription of thermal insulation box must make certain requirements, Otherwise, the quality risk of the drug transportation process is larger!

(c) May it be added that, during the transport of refrigerated trucks, they shall not change vehicles without reason, and medicines and food shall not be loaded in the same vehicle.

Reason: At present, there are two kinds of refrigerated truck drug transport, namely, zero-carload and special car transport. Special car transport is relatively standardized, because from the starting point to the destination, the whole temperature control can be monitored, and there will not be too much loading and unloading in the middle. However, in zero-load cold chain transportation, food and drugs are often mixed together, and the cost optimization is achieved through the assembly behavior of branch and trunk cars. During the operation process, multiple loading and unloading are carried out, and it is almost impossible to keep the temperature of drugs constant, which is exactly the problem that our new GSP standard aims to solve.

(d) It should be added that the interval between the recording of medicinal products during storage in cold storage and transport in refrigerated vehicles should not exceed 2 minutes at a time when the temperature values monitored are outside the specified range,..........

Reason: Because in the process of air transportation, the first is not allowed to emit mobile signals, so it is impossible to carry out sound and light alarm, and send alarm information. So it should be qualified for the sake of rigor. In the international cold chain transportation of drugs, mainly air transportation, there is no way to real-time sound and light alarm.

(e) It is recommended that the term "in transit" be removed: in-transit temperature verification should be carried out annually under extreme temperature conditions for refrigerated trucks and refrigerated (insulated) boxes in service.

Reason: in transit temperature verification caused a great waste, a large number of refrigerated vehicles in order to verify the progress of each business line is unreasonable, spent a lot of time and cost. In the case of coolers, too, the thousands of boxes that have been verified for transport twice a year are a waste of resources.

(f) The actual test of the thermal insulation performance of temperature does not need to be "in transit", but can also be achieved in a static state and a specific environment. As long as the value of the external environment of extreme high temperature and extreme low temperature is set, more environmentally friendly and economical methods can be found for verification.

(g) Added interpretation of extreme temperature environmental conditions: for example, Z high temperature above 40 degrees Celsius and Z low temperature below 10 degrees Celsius.

Reason: According to the actual test, the outdoor temperature in East China and South China in summer is 37-38 degrees Celsius, the temperature inside the closed truck can reach more than 60 degrees Celsius, and the low temperature in Northeast China in winter can reach below -30 degrees Celsius. According to the principle of fairness, a national standard should be set, otherwise the extreme temperature environmental conditions have a huge gap, which will form a large gray space.

(h) Suggested deletion: Quality management personnel should have a college degree or above in pharmaceutical secondary school or medical, biology, chemistry or other related majors, or have a junior professional title or above in pharmacy.

Reason: Talent should not be evaluated solely on the basis of education or major, and the position is "quality management", not drug research and development or manufacturing, should pay more attention to the ability and experience of "quality management". It is not in line with the spirit of reform, opening up and scientific development to evaluate and limit talents in national standards.

(i) It is recommended that additional requirements for software facilities, such as a "transport process management system", should be included as a prerequisite

(j) It is recommended to add: when transporting medicines by refrigerated trucks, the chillers shall not be turned off in the middle of the journey, and when transporting medicines in summer, loading and unloading during the journey for more than 15 minutes must be packed in refrigerated (insulated) boxes.

These suggestions are just the words of one's own mind, which may have many inconsiderate points. I hope that more experts can put forward constructive opinions to contribute to the standardization and standardization of the pharmaceutical cold chain in China, and at the same time to protect the lives and health of the people!"