On August 21st, the national standard launch meeting for the "Operation Standards for Drug Cold Chain Logistics", led by the China Union of Things Pharmaceutical Logistics Branch, was successfully held in Nanjing. According to the requirements of the National Standardization Administration, it is planned to be completed by 2020.
Drafting units such as the Logistics Branch of IoT Pharmaceuticals, the Cold Chain Transport of Pharmaceuticals Tengyi Pace, Lizhu Pharmaceuticals, China National Pharmaceutical, Shanghai Pharmaceutical, China Resources, and others 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 the China Logistics and Procurement Federation.
Yu Songhai
Chairman of Shanghai Tengyi Pace International Logistics Group
Qin Yuming, Executive Vice Chairman of the Pharmaceutical Logistics Standardization Working Group of the National Logistics Standardization Technical Committee and Executive Vice President of the Pharmaceutical Logistics Branch of the China Federation of Logistics and Procurement, first welcomed and thanked the attending representatives, and then emphasized the importance of revising this national standard. After five years of vigorous promotion, the old version of the national standard has made significant progress in the operation level of the entire pharmaceutical cold chain in China, This national standard has not only been recognized by industry enterprises, but also by national and local bureaus.
With the release of the Vaccine Management Law, there have been inconsistencies with regulations in the standards, such as the requirements for the storage time limit of temperature records. Relevant content will be improved in the later revision process.
Chairman Yu Songhai provides suggestions for the national standard and proposes the following modifications:
(a) It should be added that if the receiving area is not in the cold storage, refrigerated (insulated) boxes should be used for transportation to ensure that the temperature of the drugs is always controlled within the specified temperature range.
Reason: The current situation in China is that, except for a few large pharmaceutical distribution companies, the majority of recipients do not have compliant cold storage facilities, such as hospitals, clinics, laboratories, and individuals. Some places are located in busy urban areas, and the areas are narrow or restricted by trucks. In this case, using only refrigerated trucks for transportation cannot achieve full temperature control, and easier mobility must be adopted, More flexible operation of refrigerated (insulated) box transportation can actually achieve full temperature control of drugs.
(b) The refrigerated (insulated) box and supporting refrigerant should meet the configuration requirements for the temperature and transportation time of refrigerated drugs, and be accompanied by temperature detection and recording equipment or materials. The insulation time for maintaining a reasonable storage temperature of drugs in a refrigerated (insulated) box should not be less than 48 hours under various seasonal conditions.
Reason: If the insulation box only considers temperature without considering transportation time, it may cause overheating. In China, the territory is vast and the climate is complex. At the same time, due to the complex situation of drug transportation involving road transportation, air transportation, railway transportation, etc., the transportation time may exceed one week. Therefore, certain requirements must be made for the insulation time of the insulation box, otherwise the quality risk during drug transportation is high!
(c) Can it be added: During the transportation process of refrigerated trucks, it is not allowed to change trains midway without reason, and drugs and food are not allowed to be loaded on the same vehicle.
Reason: Currently, there are two types of refrigerated truck drug transportation: less than full load and special vehicle transportation. Special vehicle transportation is relatively standardized, as temperature control can be monitored throughout the entire process from the origin to the destination, and there will not be too many intermediate loading and unloading situations; However, in LTL cold chain transportation, food and drugs are often mixed together, and cost optimization is achieved through the assembly behavior of branch and mainline vehicles. During the operation process, multiple loading and unloading operations are carried out, making it almost impossible to maintain a constant temperature of drugs. This is also the problem that our new GSP standard focuses on solving.
(d) It should be added that during the storage of drugs in cold storage and transportation by refrigerated trucks, when the monitored temperature value exceeds the specified range, the recording interval should not exceed 2 minutes each time
Reason: Because in the process of air transportation, it is not allowed to emit movement signals first, it is impossible to conduct sound and light alarms and send out alarm messages. So for the sake of rigor, it should be limited here. In the transportation of international cold chain drugs, air transportation is mainly used, and there is no way to provide real-time sound and light alarms.
(e) Suggest removing 'in transit': In-transit temperature verification should be conducted annually for refrigerated trucks and refrigerated (insulated) containers in use under extreme temperature conditions.
Reason: In-transit temperature verification has caused great waste, and it is unreasonable for a large number of refrigerated trucks to idle on each business line for verification, spending a lot of time and cost. The same applies to refrigerated containers, where thousands or even tens of thousands of boxes are transported twice a year for verified purposes, which is a waste of resources.
(f) The actual testing of temperature insulation performance does not necessarily need to be "in transit", and can be achieved in a static state and specific environment. As long as the external environment values of extreme high temperature and extreme low temperature are set, more environmentally friendly and economical methods can be found for verification.
(g) Add explanations for extreme temperature environmental conditions, such as high temperatures above 40 degrees Celsius and low temperatures below 10 degrees Celsius.
Reason: According to actual testing, the outdoor temperature in East and South China in summer is between 37 and 38 degrees Celsius, the temperature inside closed freight cars can reach over 60 degrees Celsius, and the winter low temperature in Northeast China can reach below -30 degrees Celsius. According to the principle of fairness, a national standard should be set, otherwise there is a huge gap in extreme temperature environmental conditions, which will form a large gray space.
(h) Suggested deletion: Quality management personnel should have a vocational school degree in pharmacy or a college degree or above in medicine, biology, chemistry, or other related majors, or have a professional technical title at or above the junior level in pharmacy.
Reason: The evaluation of talents should not only be based on educational background or major, and this position is "quality management", not drug research and development or manufacturing. More attention should be paid to the ability and experience of "quality management". Evaluating and limiting 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", which should be a necessary condition
(j) Suggestion to add: When transporting drugs by refrigerated trucks, the refrigerator should not be turned off midway. In summer transportation, if the loading and unloading process exceeds 15 minutes during transportation, refrigerated (insulated) boxes must be used for packaging.
These suggestions are just words from Tengyi Qiushi's family, and there may be many thought-provoking aspects. Here, we are just throwing a brick and drawing a jade. We hope that more experts can provide constructive opinions, contribute to the standardization and standardization of China's drug cold chain, and also contribute to safeguarding the lives and health of the people
