In this case study, you will learn how the Army Pharmacy, being part of the Swiss Armed Forces Logistics Base and acting on behalf of the Swiss Federal Office of Public Health:
- implemented a GDP-compliant temperature monitoring solution for dry ice shipments and frozen goods in less than four weeks;
- thus enabled the smooth supply of nearly 9 million vaccine doses to the Swiss population to date; and
- benefited from ELPRO’s decades of industry experience in this high-priority project of the Swiss government.
Project partner: Logistics Competence Center of the Swiss Armed Forces and the Swiss Federal Administration for Pharmaceutical Products, Medical Devices and Medical Technology Responsible for ensuring the materials-related readiness of the Armed Forces Medical Service Central Procurement Office for medical supplies of the Armed Forces and the Federal Administration Swissmedic licenses for the manufacture, import, wholesale and export of medicinal products; operating license for transplant products (TpP) / gene therapy products (GT) / genetically modified organisms (GMO) Currently responsible, on behalf of the Federal Office of Public Health (FOPH): for the procurement, storage and distribution of Covid-19 vaccines to the cantons and the Principality of Liechtenstein For more information:
- https://www.vtg.admin.ch/de/ organisation/lba/armeeapotheke.html
Seamless supply of vaccines to the Swiss population during a pandemic and under high political pressure
At the end of December 2019, China officially informed the World Health Organization (WHO) of an unknown viral disease that might cause severe pneumonia. In early March 2020, the WHO classified the outbreak as a pandemic. Soon thereafter, the Federal Council declared Switzerland to be in an exceptional situation according to the Epidemic Act and thus declared the highest danger level. The procurement of a vaccine on the agile global market and its smooth distribution to the Swiss population was defined by the WHO experts as one of the most promising factors for success in combating the pandemic. The political pressure in this project continues to be high even to date, as is the fear of supply bottlenecks due to protectionist actions by countries and of a possible loss of valuable vaccine doses due to the strict requirements concerning the storage and transport conditions early on. One of the most promising vaccines requires a storage temperature of –90 °C to –60 °C and may only be transported and stored at higher temperatures for short periods of time. GDP compliance – i.e. adherence to the regulatory requirements of “Good Distribution Practice” for therapeutic products – became an unprecedented challenge for the project partner under these conditions.
Implementation of a temperature monitoring solution that meets stakeholder requirements
When it became known that the first vaccines might be available at the turn of the year 2020/2021, the Army Pharmacy, the Swiss Armed Forces’ logistical competence center, was commissioned by the Federal Office of Public Health (FOPH) in May 2020 to procure, store and distribute the vaccines. It is the only unit in the Federal state that is in possession of the necessary authorizations from Swissmedic. The time pressure was high, the exact timing and delivery quantities of the respective vaccines were not fixed until shortly before commencement of the vaccination campaign. The Army Pharmacy already had in place a temperature monitoring solution for its intermediate storage facilities. However, the storage at ultra-low temperature as well as the dispatch of the vaccines with dry ice posed a new challenge due to the lack of infrastructure. Reto Spinnler, the Army Pharmacy validation officer in charge of the project, aimed to attain the following project goals through implementation of a temperature monitoring solution: Maintaining GDP-compliance throughout, from delivery of the vaccine to handover to the customers (cantons and the Principality of Liechtenstein) Proof of the establishment and guarantee of safe storage and distribution vis-à-vis the vaccine manufacturers Reliable data quality and rapid data availability for safe, fast releases of the vaccine delivery for the next intermediate transports by the quality assurance department Implementation at short notice Easy-to-use software and hardware No transmission of geo-data (secrecy of transports and storage locations for security reasons)
ELPRO impresses with implementation of a GDP-compliant full-scale solution in less than four weeks. To minimize risk, the supplier should already have a “positive relationship” with the Army Pharmacy. Much like one of its competitors, ELPRO already had an established partnership with the Army Pharmacy for temperature monitoring of medicines. ELPRO prevailed over a competitor and also impressed with their experience from numerous projects throughout the world. In a very short time, ELPRO was able to provide a secure, proven full-scale solution consisting of technically mature state-of-the-art data loggers and a cloud database solution that met all regulatory requirements. “In projects like this, where time is of the essence and we rely heavily on the expertise of the supplier, especially soft factors play a major role in addition to meeting user requirements. ELPRO already convinced us from the very first discussions with their ready willingness to find solutions, their competence, reliability and openness.” RETO SPINNLER, ARMY PHARMACY VALIDATION OFFICER
Success factors of a project with national scope: Expert knowledge and open communication at eye level In the project, in which time was of the essence and which was affected until the very end by the delivery dates and quantities of the vaccine being unknown, the pharmaceutical knowledge, the knowledge of quality assurance and official regulations as well as the implementation competence of those involved in the project at Army Pharmacy were important success factors. “Despite the strong time pressure, we managed to devise an open culture of discussion and an open working atmosphere involving everybody. The direct, trusting exchange and mutual acceptance of expert knowledge helped us to keep everyone on board even in critical phases, and to focus on problem solving.” DANIEL REICHEN, GLOBAL KEY ACCOUNT MANAGER, ELPRO-BUCHS
The successful implementation of the solution at short notice was also characterized by ELPRO’s willingness to provide support straightforward and unbureaucratically, even beyond the actual core tasks. Owing to the direct communication at eye level and the open discussions, it was feasible to solve problems quickly.
