Across the pharmaceutical and healthcare landscape, an increasing volume of approved pharmaceutical products must be temperature controlled from the moment they are manufactured until shortly before they are administered. Such products create high stakes for all partners in the complex supply chain, which must now be entrusted to keep the fragile products within their specified temperature range — refrigerated (2 to 8°C), controlled room temperature (15 to 25°C), frozen (-20 to -80°C) and deep frozen (-150°C and colder) — no matter what may arise during storage and transit. Today, such high-value, temperature-sensitive therapies include oncology medications, biologic therapeutic agents, novel cell and gene therapies (CGTs), vaccines (the COVID-19 vaccine and others) and more.

With any temperature-sensitive pharmaceutical shipment, plenty can go wrong along the way. If travel delays and other complications aren’t addressed quickly, these therapies are at risk of experiencing temperature excursions that could lead to reduced efficacy resulting in spoilage and discard. Spoilage has significant financial consequences for drug manufacturers and potential life-threatening consequences for patients who aren’t able to receive their treatments at the prescribed time.

Unfortunately, there is no globally adopted regulatory framework in place today to govern uniform practices for partners in the pharma cold chain. Instead, participants typically rely on a patchwork of voluntary industry guidelines and best practices.

Good Distribution Practice (GDP) provides an internationally accepted quality system that helps create greater uniformity of policies and protocols related to product packaging, shipping, storage and transportation, with the goal of ensuring the integrity of temperature-sensitive pharmaceutical products and reducing risk.

Overall, the GDP guidelines serve two purposes:

• To codify practices needed to optimize the packaging and transportation of temperature-sensitive products and ensure they remain fit for human consumption.
• To provide a systematic framework to meet the needs of a regulatory audit.

Key Factors for GDP Compliant Shipments

Adherence to GDP guidance can help pharmaceutical manufacturers ensure that every patient receives their treatment and ultimately reduce the overall cost of manufacturing operations as loss due to spoilage could be drastically reduced. There are five key elements of the GDP guidance critical to preserving therapeutic efficacy. Shippers can now definitively meet each of these guidelines for air cargo shipments with real-time shipment visibility.

Product traceability

Real-time GPS location tracking allows all parties involved in a shipment – the pharmaceutical manufacturer, airline or freight forwarder – immediate insight to the shipment’s position throughout the entire journey and provides details of any route deviations that may create unsustainable delays. Armed with this information, both parties have the opportunity to intervene to preserve the shipment and prevent spoilage.

Product efficacy

Temperature monitoring devices integrated into the air cargo container allow customers to receive real-time alerts when either cargo or ambient temperature deviates from the set threshold for a specific shipment. Stakeholders can again, intervene if needed to resolve the issue or easily confirm that it was a temporary issue and no product excursion occurred allowing the therapies to continue the journey and be safely used.

Product safety

In addition to ensuring that the product shipment remains within its setpoint temperature window, air cargo containers equipped with sensors on the doors and linked to a shipment visibility platform can offer real-time alerts when doors are opened or closed (and for how long). This provides important insight to help reduce not only temperature excursions but other potential threats to these therapies.

Damage prevention

The ability to detect and capture data related to shock and tilt events, and create related alerts, provides insight into how the products are being handled during transit, and capture a history of events that may be needed, should the product arrive in a damaged condition and require an assessment.

Compliance record

With such rigorous data collection throughout the journey, and the ability for all stakeholders to always have in-depth shipment visibility, shippers and their pharmaceutical company partners are able to receive critical information in real-time and create detailed GDP-compliant reports at any point along the container’s route.

Beneficial Side-Effects of GDP Compliance 

GDP guidelines are in place to protect pharmaceuticals so they arrive to the patient at maximum efficacy. If this happens with 95% of shipments, the cost to distribute pharmaceuticals will go down drastically because so much less will be lost to spoilage.

For pharmaceutical manufacturers, this means selling those therapies rather than losing the funds invested. For freight forwarders, airlines and warehouses, happier customers and ideally more shipments of more pharmaceuticals. For patients, a reliable supply chain to receive medicines and vaccines on time and the peace of mind that it is in perfect condition.

While spoilage risk can never be completely eliminated, with shipment visibility supporting GDP compliance, shippers can more easily make efforts to reduce it. Doing so will ultimately strengthen the cold chain and safeguard high-value, temperature-sensitive therapies and provide peace of mind for everyone from the manufacturer to the patient.

CSafe Global Shipment Visibility

CSafe launched the first real-time shipment visibility for air cargo containers in December 2020. We are currently retrofitting our entire fleet with tracking devices that allow the location and condition of each container to be tracked in real-time via a cloud-based platform.