Concise Guide to Pharmaceutical Logistics

Imagine a life-saving vaccine or a critical medicine becoming useless before it ever reaches the person who needs it. This isn't just a hypothetical problem, it's a daily reality in the pharmaceutical supply chain. When a product isn't handled correctly, even a small change in temperature or a bump during shipping can make it ineffective or even dangerous. This isn't just a financial loss, it poses a direct and serious risk to human health.

This is where pharmaceutical logistics comes in. It's a specialized type of supply chain for safely storing and transporting medicines, vaccines and other health products. Unlike regular shipping, this process follows strict rules to ensure product integrity from the factory all the way to the patient. This includes managing a cold chain which is a system of temperature-controlled environments. It relies on advanced tracking technologies and special packaging to guarantee that the medicine you receive is as safe and effective as it was when it was made.

Temperature-sensitive products also need protection from other factors, such as humidity, light and vibration. Some medicines are even considered dangerous and require special handling and transportation conditions. For every pharma product, getting it to its destination safely and on time is the top priority.

Temperature Ranges and Methods of Control

Storage, as well as transportation, of pharmaceuticals must be carried out under specific requirements. Exposure to light, humidity or outside temperature must be regularly controlled and logged at regular intervals. For this purpose, it is common to use temperature and humidity loggers, GPS monitors and other devices which notify the stakeholders about temperature excursions or other deviations.

The temperature spectrum for pharmaceuticals ranges from ambient, or controlled room temperature (20°C to 25°C), to refrigerated (2°C to 8°C), to frozen (below 0°C to as low as −150°C) or cryogenic (below −150°C to absolute zero).

Temperature-Controlled Shipping Systems

To maintain temperatures for pharmaceuticals during transport, active or passive shipping systems may be used considering the manufacturer’s requirements, time of the year, weather conditions, distance, etc.

Refrigerated Transport

This involves transport using ordinary vehicles with insulated, thermostatically controlled cargo compartments, enabling the temperature range to be maintained. Refrigerated vehicles may come in the form of trucks and vans of various dimensions, equipped with electronic control systems to manage and log temperature. Some smaller trucks and vans rely on the engine to power the refrigeration unit, while larger vehicles have independently powered refrigeration units.

Passive Shipping Systems

Passive shipping systems involve using insulating material and temperature-stabilizing media such as dry ice, gel packs, etc for keeping temperatures within a desired range. While minimizing human or external input to operate, the passive shipping system can maintain temperature for a limited period of time, making it a good solution for shipping pharmaceuticals at ambient temperatures over short distances by road or longer distances by air.

Passive cooling can be used as a stand-alone solution or alongside other major types of temperature control systems as an additional layer of protection. When used as a stand-alone solution, it must only be used if the route, distance, weather conditions and the container meet the required criteria for temperature control.

Active Shipping Systems

Active shipping systems are widely used in air freight and sea freight and involve thermostatistically controlled cargo containers, which allow for longer transport times and better reliability. Such containers come in two types, cooling only and cooling and heating. In air freight, these containers are powered via internal batteries and temperature-stabilizing media such as dry ice (cooling types only) or phase change materials (heating and cooling types). In seafreight, active shipping systems rely on the ships’ onboard power supply such as compressors or heat pumps. Shipping containers in both air freight and sea freight are generally leased by manufacturers, carriers or third-party logistics service providers.

Managing Shipping Risks for Pharmaceuticals

Quality Management

Routes can be long and complex, involving multiple carriers and transit points and no single party has ultimate control over the shipment’s integrity. This raises the stakes for all parties involved, especially the freight forwarders who are often responsible for managing the overall movement of the shipment - from the factory floor to the clinic. A properly implemented quality management system helps reduce risks of temperature excursions, time delays or mishandling across multiple touch points along the supply chain.

Industry Standards & Regulations

Whether you outsource your pharma logistics to 3PL providers or have your in-house logistics team directly managing your supply chain, it is important that the personnel involved in handling pharmaceuticals are equipped with appropriate training in accordance with the industry standards, both at national and international levels. Some of the commonly used international regulations / standards in the pharmaceuticals industry include:

• Temperature Control Regulations (TCR) - IATA

• Perishable Cargo Regulations (PCR) - IATA

• CEIV Pharma Program - IATA

• European Union Good Distribution Practices (EU GDP)

• World Health Organization Annex 5

Importance of Communication

Shippers are responsible for providing forwarders with comprehensive and accurate details about pharmaceutical products, including any specific transport requirements. The forwarder will then use these instructions to manage all logistical phases.

If the pharma product is classified as dangerous goods, shippers must provide an SDS (Safety Data Sheet) for the product. Paragraph 14 of this document contains complete information about the cargo, including proper shipping name, UN number, hazard class, etc. The document also states manufacturer's instructions for transportation by various modes of transport, requirements for packaging, labeling, etc.

The freight forwarder is required to carefully monitor the movement of cargo through all touchpoints, hire qualified third parties, and ensure highest possible shipment visibility for the customer. The forwarder must also check the availability of import, export or transit permits in the countries involved and ensure that the outer packing and labeling accurately reflect the contents of the actual shipment.

The freight forwarder is expected to register any deviations from the established standards during transportation, take corrective and / or preventive actions and coordinate its actions with the customer.

To ensure reliable transportation of your pharmaceutical products, you need to turn to qualified and experienced freight forwarders. We at Delta Global Solutions offer our clients a full range of medical logistics services.

How Delta Global Solutions Can Help

Ensuring the integrity and timely delivery of pharmaceutical products requires a logistics partner with proven expertise in the pharma industry. Delta Global Solutions offers comprehensive pharmaceutical logistics services, including temperature-controlled transportation, regulatory compliance and quality management. Our solutions are designed to safeguard product efficacy and support the highest standards of patient safety across global supply chains. Contact us today to learn how we can support your pharmaceutical logistics needs.

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FAQ:

1. Do you need a license for pharmaceutical transportation?

Yes, in most cases a license or specific certification is required to transport pharmaceuticals, particularly when temperature-controlled logistics are involved. Regulatory requirements for pharma transport vary by country, so it’s essential to check local compliance standards and ensure your logistics provider is fully certified for pharmaceutical shipping.

2. Is shipping pharmaceuticals illegal?

No, shipping pharmaceuticals is not illegal, but it is heavily regulated. Strict compliance with pharmaceutical shipping laws and international regulations is required to ensure product safety, maintain quality and prevent counterfeiting throughout the supply chain.

3. What should you know before shipping pharmaceuticals by air?

Before shipping pharmaceuticals by air, it is essential to follow Good Distribution Practices (GDP), ensure temperature-controlled packaging and comply with aviation and customs regulations. Proper documentation and secure handling are also critical to avoid delays or product damage.