Special features of pharmaceutical logistics

Have you ever wondered how pharmaceuticals get safely from the manufacturers to the pharmacies, hospitals, doctors and online orders of medicines to the end users? How is the quality of pharmaceuticals ensured in pharmaceutical logistics? What regulations apply and what means of transport are used in the pharmaceutical industry and logistics?

A whole series of national and international legislation and regulations apply to pharmaceutical logistics. The most important of these are the Medicinal Products Act, Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP), the Hazard Analysis and Critical Control Points (HACCP) guidelines, the regulations of the US Food and Drug Administration (FDA), the guidelines of the World Health Organization (WHO) and the regulations for air transport of the International Air Transport Association (IATA). At the national level, the Handling of Hazardous Substances Ordinance and the Technical Rules for Hazardous Substances 400 (risk assessment for activities involving hazardous substances) also apply to the handling of pharmaceuticals, among other things. The Medicinal Products Act regulates the proper and safe supply of medicinal products for human and veterinary use in Germany. Good Distribution Practice (GDP) encompasses all the necessary measures and requirements for ensuring the quality and integrity of medicinal products by monitoring the distribution chain. Although the EU GDP guidelines are primarily aimed at pharmaceutical wholesalers, compliance with these measures is required of all players and responsible employees throughout the entire supply chain. For example, transport companies and warehouses must also meet the requirements of GDP. In the GMP guidelines, the chapter on ‘premises and equipment’ specifically refers to aspects of pharmaceutical logistics – particularly with regard to the requirements for the storage and transport of pharmaceuticals. The regulations and guidelines of HACCP are aimed at the preventive identification and control of food safety risks in order to ensure consumer safety. By systematically monitoring critical control points in food production, these guidelines help to prevent food poisoning and ensure legal compliance. The IATA regulations are designed to ensure that pharmaceutical products are transported and stored under optimal conditions by air.

Both GDP and GMP prescribe certain security measures and controls, particularly with regard to the logistics of pharmaceutical products. In addition, the Act for more Safety in the Supply of Medicinal Products (GSAV) was enacted in August 2019. It aims to increase the security of the supply of medicinal products and to strengthen the public's trust in the supply of medicinal products. According to GDP, pharmaceutical products must be stored and transported under conditions that comply with the manufacturer's specifications. This includes temperature control and monitoring to ensure that the products maintain their quality during transport and storage. In addition, seamless documentation of all processes is required. Regular inspections and audits must be carried out to ensure compliance with all GDP guidelines. The GMP requires that the storage conditions meet the specific requirements of the medicinal products. This includes monitoring environmental conditions such as temperature, humidity and light exposure. GMP also includes requirements for the safe transport of pharmaceuticals to avoid contamination or loss of quality during transport. This may include special containers or transport conditions, such as maintaining certain temperatures. In addition, seamless documentation of all processes and procedures related to storage and transport is required. The records are crucial for traceability and for audits. The GSAV requires the improvement of the transparency of supply chains, in particular through more precise information on the origin of the active ingredients and the production routes. The main provisions of the law include increased controls and documentation requirements for manufacturing processes, in particular for imports, as well as extended reporting requirements for manufacturers with regard to risks and side effects. The law also promotes systems for improved traceability and transparency to facilitate monitoring and enable rapid responses in the event of recalls. In addition, stricter requirements for the supply chain and preventive measures against supply bottlenecks and increased quality standards for generics are being called for through stricter bioequivalence tests.

Die Lieferung von sensiblen Medikamenten, wie Impfstoffen und biologischen Produkten, stellt die Pharmalogistik vor zahlreiche Herausforderungen. Eine der wichtigsten Anforderungen ist die strikte Temperaturkontrolle während des Transports und der Lagerung, um die Wirksamkeit der Medikamente zu erhalten. Zudem erfordert die Wahrung der Sicherheit und Integrität der Medikamente wirksame Schutzmaßnahmen gegen Diebstahl, Verfälschung und Beschädigung. Die Einhaltung einer Vielzahl nationaler und internationaler Vorschriften kompliziert die Logistikprozesse besonders bei grenzüberschreitenden Lieferungen. Generell werden eine präzise Dokumentation und Kenntnisse der gesetzlichen Bestimmungen gefordert. Lieferengpässe z. B. durch plötzliche Nachfrageänderungen, die schwerwiegende Folgen für die Patientenversorgung haben können, müssen unbedingt vermieden werden. Die Implementierung fortgeschrittener Rückverfolgbarkeitssysteme, um beispielsweise Rückrufe effizient managen zu können, ist essenziell. Darüber hinaus ist die Flexibilität der Lieferkette entscheidend, um sich schnell an unvorhersehbare Ereignisse wie unterbrochene Lieferwege anzupassen.

Pharmaceutical products are usually stored at room temperatures of 15-25°C, whereas many medications require refrigerated storage at temperatures of 2-8°C. In a low temperature environment, molecular movement slows down, the reactivity of chemical compounds decreases, germ growth is suppressed and the stability and shelf life of medications improve. Even minimal temperature fluctuations can have a significant impact on the lifespan and effectiveness of pharmaceuticals. According to GDP guidelines, the prescribed storage conditions must be strictly adhered to throughout the entire transport route, as specified by the manufacturer or noted on the packaging. In particular, the temperature of pharmaceuticals requiring refrigeration should be between +2°C and +8°C throughout, in order to maintain the integrity of the cold chain. Adherence to these conditions is required by the German Medicinal Products and Active Pharmaceutical Ingredients Ordinance (AMWHV) and the GDP. Logistics service providers that want to enter the pharmaceutical sector are required to obtain a GDP certificate. According to the German Logistics Association (BVL), the process is demanding and complex and is monitored by the regional councils of the respective federal states. The specific requirements vary from state to state.

When transporting temperature-sensitive pharmaceuticals, there are various categories such as those requiring refrigeration, those requiring transport at room temperature and cold chain products, whereby the latter require constant temperature maintenance throughout the entire supply chain. Cooling during transport can be done either actively with refrigerated vehicles or passively with insulated containers. Cold storage warehouses or refrigerators are usually used for storage. Temperature loggers and RFID transponders are used to monitor the temperature. Bulk deliveries to pharmaceutical wholesalers and bulk purchasers such as hospitals are carried out using temperature-controlled trucks that comply with GDP guidelines. GDP requirements also apply to cool boxes. Cold packs must not come into direct contact with the pharmaceuticals and must be positioned accordingly. In its fact sheet ‘Kühllagerung von Arzneimitteln’ (Cold Storage of Medicinal Products), the Federal Union of German Associations of Pharmacists points out that staff must be trained in the correct handling of insulated containers – which varies according to the season – and in the reuse of cold packs. In addition, a control system should be implemented that prevents the inadvertent use of insufficiently cooled batteries and ensures a clear separation between frozen and chilled elements.

BITO's passively cooled Pharmabox system includes the reusable MB container, available in sizes with 4 and 15 litre capacities, together with a thermal insulation set consisting of inlays and various cold pack solutions. This system is complemented by the Smarthub gateway & beacon monitoring system, which captures important data in real time, serves as a digital seal when storing and transporting pharmaceutical items, and enables GxP-compliant handling of sensitive goods. The MB containers are made of robust plastic and have an inlet for the Smarthub. A beacon can be installed inside the container for precise temperature and humidity monitoring, whereby both parameters are continuously recorded and documented in accordance with GDP. The asset tracking system minimises the risk of theft and tampering and ensures the consistent quality of medicines and pharmaceutical products during transport. In the event of deviations in temperature and/or humidity, the Smarthub sends an alert. The current geolocation of the assets can also be provided on request.