Stanislav Smirnov, Head of the quality department of NC Logistic, a specialized 3PL operator, talked with GxP News about how drug transportation and storage system is becoming a new critical infrastructure for the country.
How important is the logistics component in the drug supply chain from the manufacturer to the patient?
The stage of storage and delivery of medicines is critically important both for the health of the patient who receives the drug and for the manufacturer. If something goes wrong with the drug, it is primarily the manufacturer who will suffer financial and reputational losses.
At the same time, a pharmaceutical company cannot, and should not, be responsible for the entire supply chain of the drug. its task is to produce medicines. Pharmaceutical manufacturers normally have only limited storage areas. And when, for example, it prepares for seasonal diseases by increasing the production of corresponding drugs, it needs the services of a specialized logistics operator, at least in order to avoid overstocking the warehouse.
A lot of orders also come from foreign manufacturers. A logistics operator collects their medicines at the customs warehouse and ships them to the distributor or directly to pharmacies upon the customer’s order. But even when we work with a domestic pharmaceutical company, whose factory is located, say, in Central Russia, the tasks of delivering the drug to different regions of the country is still challenging. It is necessary to have some intermediate storage sites for drugs. And the longer the shipment distance, the more difficult it is to provide quality control of the cold chain.
What is quality control in drug transportation?
There are many control mechanisms, including measures to validate vehicles and check the operability of equipment throughout the drug delivery chain.
NC Logistic has its own fleet, and we also partner with carriers, which we select based on very strict criteria. Special attention is paid to the transportation of medicines that must be stored at low temperatures. There may be hundreds of millions of rubles worth of such goods in one truck, which determines the direct financial losses in a situation when the vehicle breaks down and the medicine unfreezes, for example. We offer the service of reicing and refrigerating elements replacement: not only is the drug transported in a refrigerator, but it is also placed in thermal containers with refrigerating elements. Reicing will help to maintain the temperature regime for many hours, even if the truck stops somewhere amid the steppe in the summer.
Another component of ensuring compliance with the requirements to the cold chain is the fact that we have established contacts with partners who will be able to take over the transportation of the temperature-sensitive cargo, if necessary, including on the most remote sections of the route.
What does the warehouse of a specialized 3PL operator look like?
We have three locations: Northern Domodedovo, Chekhov-2, and Yuzhnyie Vrata industrial park, with a total area of 120,000 sq. m.
Of these, 9,000 pallet positions are in medium-temperature refrigerating chambers, with temperatures from +2 to +8 degrees. Other 3000 pallet positions are in chambers with a regime designed for storing immunobiological preparations, with temperatures as low as minus 30 degrees. We are confident in our ability to carry out scheduled preventive repairs on a 24/7 basis, without turning off the equipment and putting the products at risk. To protect the products against power outages, we have several backup grids, as well as some powerful diesel generators. With our large stock of consumables and spare parts, we can have vehicles and equipment repaired even on the night of January 5, during the long holidays.
All processes are serviced by a validated stock control system, which enables each participant in the chain to find out what stocks are present in a particular warehouse.
Is the development of the pharmaceutical market leading to higher demand for the services of specialized logistics operators?
Over the past three years, I have seen a significant increase in the volume of requests from our clients. They are increasingly more aware of the importance of the intermediate logistics link, since a pharmaceutical company invest huge amounts in the production of drugs, and there is a risk of losing the money if the drug is spoiled because the company decided to save a little on storage or transportation.
We witness an evolution of the market: strong players cooperate with logistics operators and become even stronger, while weak ones face a choice of either keeping up with the trends or facing difficulties.
For a manufacturer, the construction of its own warehouse centers usually involves a very long-term investment, which does not pay off soon. The rapid development of the pharmaceutical industry makes it necessary to outsource logistics. By the way, this approach is also stimulated by legislation. From September 1, the regulation on licensing of pharmaceutical activities comes into effect (Order No. 547 of March 31, 2022).
What role did the coronavirus pandemic play in reinforcing this trend?
It was the pandemic that formed this trend. Our company has become one of the key participants in the chain of COVID-19 vaccines storage. For example, the temperature regime for Sputnik V is 18 degrees below zero, and higher temperatures are not allowed. Before the epidemic, relatively small quantities of medicines and vaccines were transported and stored under such conditions. As the participants had to deal with huge quantities of the new vaccine, that became a real challenge for all of us and created a need to upgrade the infrastructure to a great extent. As a result, the whole chain has changed, both the carriers’ chain and that of medical and preventive institutions. All vaccination centers installed freezers and backup cooling capacities to avoid damage in case of any electricity supply failures; they did not use such equipment before. I would like to note that our company, together with our partners and Roszdravnadzor, took part in the implementation of a national project of COVID-19 vaccination. Everyone was united by a common goal – to launch vaccination in the country. Every participant did their best, realizing that no mistakes could be tolerated.
How do your drug delivery practices help when you work with foreign pharmaceutical companies?
There was some confusion in the international logistics of pharmaceuticals in late February and early March. Then the supplies got back to normal, and the patients continue to receive their medicines. Pharmaceutical manufacturers understand their responsibility to consumers and are interested in continuing cooperation.
Before concluding an agreement with a logistics partner, pharmaceutical companies conduct an audit of its activities. The client must thoroughly study the business model and the site in a few days and make their verdict. Moreover, many clients that already work with us conduct such audits at least once a year. We have more than 90 clients, and we see audits primarily as sharing experience. Our developed infrastructure and the proven drug transportation and storage model mean that the clients understand our procedures at every stage easily, and we are ready for any professional inspection at any time. This becomes a competitive advantage.
However, the trend of 2022, which will certainly continue in the future, cooperation rather than competition between logistics operators. My colleagues and I work in the same field of interests, helping each other. These connections and the smoothness of business processes form a new, critical infrastructure for the delivery of medicines in the country.