A Complete Guide To Shipping Pharmaceuticals

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Logistics is considered a mission-critical component of the pharmaceutical industry since its activities are extremely sensitive to time and quality assurance. 

Despite the pharmaceutical industry facing unprecedented challenges related to globalisation and government controls over pricing, major challenges still lie in ensuring optimal shipping. 

This is because, fundamentally, pharma products require temperature-controlled storage and distribution, with strict regulatory control. 

The industry is striving to deliver life-saving products to the end customers, at the right time and place, in a secure manner and at a competitive operational cost. This is why we thought it prudent to uncover some of the elements that underpin the shipping of pharmaceuticals. 

How are pharmaceutical products transported?

Pharma products are typically transported in refrigerated containers called offshore reefers similar to the 10ft offshore refrigerated containers we provide.

These reefers usually undergo routine inspections to ensure they are in satisfactory condition to maintain medicinal inventory at correct temperatures.

Generally, pharma logistics demand strict adherence to regulation codes to ensure drugs and vaccines are safely delivered, without spoilage or losing their potency. 

However, pharma supply chain tasks are very challenging as most shippers are required to uphold cold chain procedures whilst preventing theft in transit, and implementing special precautions to move specialised pharma products.

This is because pharma shipping procedures are arguably a matter of life and death as mismanaged shipments put the health of many at risk. 

What is involved in pharmaceutical logistics?

Fundamentally, pharma logistics require special conditions to store drugs, and preferably fast delivery. 

Air transportation is the fastest option, especially for long distances. However, due to limited equipment, standardisation and transparency, and high costs involved, sea transportation is more prevalent and preferred nowadays for large shipments.  

Sea transportation can easily accommodate specialised refrigerated containers (reefers) and better supply chain organisation. Overall, despite the high risk involved during drug handling, road and sea carriers seem best placed to control the whole pharma shipping process with refrigeration mechanisms.

These mechanisms, like offshore reefer containers, allow consistent control of the conditions in which the pharma products are kept, as well as transportation of pharma that requires unique temperature ranges.

Read: &#;Offshore reefer container temperature range.&#;

Besides appropriate temperature management, shippers also need to keep a keen eye on air humidity. For example, medicinal products should not be in direct contact with ice packs. 

Additionally, pharma products should be collected directly from the manufacturer or a warehouse, with the entire journey documented&#; for example, time, changes in container temperatures, etc. 

Overall, the pharma logistics cold chain process is underpinned by four key steps: 

• Supply:

   This initial phase involves manufacturing and packaging the drugs, vaccines or pharmaceutical products.

• Transportation: 

  This next step typically involves transporting the pharma products in refrigerated or insulated containers/trucks. Usually, these trucks/containers usually undergo routine inspections to ensure they are in optimal condition to maintain inventory at correct temperatures.

• Storage: 

  In this phase, pharma products are kept in cold storage in a refrigerated warehouse before being distributed. The refrigerated warehouse essentially acts as a middle ground before the products arrive at their final destination.

• Market: 

  This last step in the pharma cold chain logistics process focuses on the delivery to the final destination where the pharma products are sold or administered.

Pharmaceutical transportation regulations

Drug distributors typically commit themselves to following a variety of standardised rules. For example, drugs being stored in suitable conditions at any moment to avoid the risk of contamination by external factors.

Drug distributors also have a duty to institute procedures for tracking medicines and locating defective products to take them out of circulation.

Generally, pharma transportation regulations encompass everything from refrigerated vehicle designs and temperature-control abilities to warding off potential contamination. 

Similar to other time-sensitive and hazardous materials, sensitive pharma products require strict, documented and standardised training procedures covering: 

• Cleanliness:

    Any area pharma products spend time at cannot risk contamination.

• Temperature control:

   Since some drugs are rendered useless or even hazardous if the environment is not temperature-controlled to exact specifications.

• Protection:

   As pharma products can be a prime target for theft. For example, shipments of opioids are usually targeted by thieves. As such, it&#;s imperative to ensure that drugs arrive at hospitals or pharmacies with unbroken seals.

• Documentation:

   Documentation is arguably the bread and butter of pharma logistics. This means that pieces of training should cover good record keeping.

What are the risks involved in shipping pharmaceuticals?

Any valuable shipment comes with inherent high risks, and pharma products are no different. 

For example, without proper temperature control mechanisms, drugs can become ineffective or even deadly. In fact, a minor change of as little as three degrees in temperature can ruin a drug product. 

This is because more specialised pharmaceuticals come with more stringent temperature requirements. So, it is imperative to always communicate with shippers your unique freight needs in order to have safe delivery. 

With this in mind, shippers must also always be diligent and proactively keep a keen eye on their temperature logs to prolong the effectiveness of drugs.

Another risk is theft. As alluded to earlier, prescription drugs like opioids usually attract bad actors. Therefore, most pharmaceutical warehouses are encouraged to institute high-security measures. However, most theft incidences occur while in transit. 

Important aspects in pharmaceutical shipping

1. Packaging is crucial

Because pharma packages are prone to shifting during the shipment process, it is important to ensure proper packaging. To further exacerbate issues, during the shifting process chemical reactions of the products can be altered. Or equipment could break. 

To avoid the losses that could occur from such unpredictable occurrences, pharma products need to be appropriately fitted into containers with packaging options like individual compartments, ice, or even added light mechanisms.

2. Maintaining and tracking pharmaceutical temperatures

The integrity of the cold chain is one of the most important elements of pharma supply chain management. Most pharmaceuticals need storage between 55-77 degrees Fahrenheit. 

Unfortunately, temperature fluctuations of only a few degrees can damage the efficacy of some products. So, &#;controlled&#; room temperatures are recommended that do not fluctuate drastically.

3. Choosing the right reefer containers

An active cold chain needs transportation modules with built-in cooling units designed to maintain constant temperatures. The modules are referred to as &#;reefers&#; and offer a regulated environment to protect pharma contents against external changes in temperature.

Such containers or trailers typically maintain sealed walls and even reflective roofs to block sun rays to prevent materials from rotting, deteriorating, or becoming hazardous.

Check out the range of products under offshore reefer containers at MGSIcestorm.

4. Understand the laws and regulations

Like alcohol and perfumes, pharma items can be considered hazardous substances. As such, they are typically subject to stringent government regulations and laws. 

So, determining how to ship your pharma products, you must be aware of the laws and ensure your shipping process follows them.

5. Keep proper licensing

In addition to knowing the law, using a shipping company that maintains proper licensing is key. There are typically specialised licensing requirements dictated when shipping pharmaceuticals. 

While you don&#;t need to know details about these requirements, you must ensure your chosen shipping company knows the requirements and holds all necessary licensing to operate a pharma shipping line.

6. Documentation is important

Inspections are part and parcel of pharmaceutical shipping. 

If you want to learn more, please visit our website Safe Fast Shipping of Pharmaceutical Intermediates .

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Whenever a shipping pharma container is received, extensive inspection is performed for any signs of contamination. 

After inspection, consistent documentation and record keeping is required to highlight broken pallets, torn stretch wraps, or even pest infestations. 

7. Stay insured

Insurance is necessary as pharmaceuticals shipping is full of inherent risks. As with any &#;risky business&#;, insurance covers uncertainty to your business, and your shipment.

Unfortunately, the level of uncertainty can significantly affect one&#;s bottom line, if unprotected. However, with insurance cover that allows one to show that they followed industry standards to avoid any loss, insurance companies can promptly payout to help mitigate the financial damage that may occur during the shipment process. 

8. Hygiene

Facilities that handle and store pharma products must be large enough to allow proper cleaning, and airflow around pallets. 

Furthermore, they should also boast separate quarantine areas for medications which are damaged, expiring, or deteriorating. 

Hygiene is critical as any signs of infestation from insects, or animals will cause a pharma shipment to be unusable.

9. Security

Facilities for pharma storage need security mechanisms that control and restrict access into spaces where medications are being stored. 

For example, surveillance cameras, access control keys, and automatically locking doors.

10. Telematics for Cold Chain Monitoring

Telematics technology allows fleet managers to better control their cold chain fleets by providing continual data on the specific temperatures of refrigerated cargo. Generally, from refrigerated warehousing to intermodal storage, pharma shipping chains need a detailed history of temperature conditions. 

Pharmaceutical shipping companies: Should you partner with one?

The shipment of temperature-sensitive pharma products is highly challenging, as businesses involved in the service must establish quality risk management mechanisms to achieve the goals of patient safety, without apprehension of drug regulatory measures. 

As such, it is important for pharma entities to partner with companies that adhere to strict regulations set by government authorities and are licensed appropriately to handle temperature-sensitive goods. 

Pharma shipping companies that fit this description are rarely prone to instances of product degradation due to incorrect shipping, or temperature sensitivity damage due to a broken cold chain.

Conclusion

Pharmaceuticals shipping is a lucrative industry that also carries high risk and responsibility. Hence, the strict regulation. 

With this in mind, pharma industries and organisations should always ensure to choose a freight forwarder with:

• Extensive experience in pharma transportation. 

• Familiarity with legal regulations regarding the transportation of drugs, including specific temperature-sensitive product requirements.

• A reliable cold chain where medicines are stored in constant temperature and humidity is controlled on an ongoing basis with appropriate sensors.

• Good documentation procedures, including the recording of potential inadequacies, since any improperly stored drugs can negatively affect people&#;s health.

Learn about our DNV 2.7-1 certified 10ft & 8ft offshore reefer container for your pharma shipping needs.

Reach us at MGS Icestorm for more information on shipping your pharma products safely.

Business Director

A graduate (Business) from KDU, Jason Tan, is the current Business Director (Sales) for MGS Icestorm and has been associated with the company for the past 10 years.

With over 13 years in the shipping industry, he has had a significant contribution to Malaysia&#;s oil and gas industry in the engine and boat supply sector.

His expertise includes managing offshore catering business, offshore reefer containers, AI technology, offshore gas tanks, A60 pressurized cabins, etc. His contributions have helped establish MGS, in partnership (joint venture) with Thermo King and Honeywell to produce state of art Offshore Reefer Container products.

Key Takeaways

• Importance of Compliance: Ensuring safe and compliant transport of pharmaceuticals is critical for maintaining medication integrity and global health outcomes.
• Reliable Systems: Reliable transportation systems prevent spoilage and maintain optimal conditions for life-saving drugs, supporting public health systems worldwide.
• Utilizing the Right Tech: Advanced technologies like temperature monitoring, GPS tracking, and regulatory compliance systems are essential for efficient and secure pharmaceutical transportation.

As a shipper, ensuring the safe and compliant transport of pharmaceutical products is critical within the freight industry.

It is not only crucial for maintaining the integrity of the medications but also has broader implications for global health outcomes.

Reliable transportation systems are fundamental to ensuring that life-saving drugs avoid spoilage and maintain optimal condition, thereby supporting public health systems worldwide.

It&#;s also worth noting that different pharmaceuticals require varying temperature ranges to maintain their stability and quality during transit.

Here are the common temperature ranges for reefer trailers used in pharmaceutical transportation:

TemperaturePurposeControlled Room Temperature &#; CRT15°C to 25°C (59°F to 77°F)Many pharmaceuticals, including most oral medications, are transported at this temperature range.Refrigerated &#; Cold Chain2°C to 8°C (36°F to 46°F)This range is crucial for vaccines, biologics, and certain medications that require a cool environment to remain effective.Frozen-20°C to -10°C (-4°F to 14°F)Certain pharmaceuticals, such as some biologics and specialty medications, require freezing temperatures to maintain their potency.Deep Frozen-80°C to -20°C (-112°F to -4°F)Highly sensitive products, like certain vaccines (e.g., some COVID-19 vaccines), need deep frozen conditions to ensure their stability.CryogenicBelow -150°C (-238°F)Used for extremely sensitive biological samples and certain cell and gene therapies that must be kept at ultra-low temperatures.

Challenges in Pharmaceutical Transportation

Transporting pharmaceuticals presents unique challenges that can significantly impact the health sector globally.

If not addressed these challenges can lead to potential risks and losses. These challenges include:

Temperature/Condition Sensitivity

• Many medications require strict temperature control to maintain their efficacy. Fluctuations during transit can render them ineffective, posing significant risks to patient health.
• Solution: Implement advanced temperature monitoring and control systems to ensure consistent conditions throughout transit. Utilizing insulated packaging and climate-controlled transportation can help maintain required temperatures.

Regulatory Compliance

• Navigating the complex web of international and local regulations is a constant challenge, requiring meticulous planning and documentation.
• Solution: Invest in regulatory compliance software and hire experts to ensure all documentation is accurate and up to date. Routine training for staff on the latest regulations can also prevent non-compliance issues.

Security Risks

• Pharmaceuticals are high-value targets for theft, requiring enhanced security measures during transit.
• Solution: Utilize GPS tracking, tamper-evident seals, and secure packaging. Collaborating with specialized security providers and training personnel on security protocols can further mitigate theft risks.

Logistical Complexities

• Coordinating the logistics of timely delivery across multiple geographies, especially to remote areas, can be daunting and prone to disruptions.
• Solution: Leverage logistical technologies like route optimization software and real-time tracking systems. Establishing reliable partnerships with local logistics providers can also ensure timely and efficient deliveries.

Handling Specialties

• Certain pharmaceuticals require specialized handling and equipment, complicating their transportation.
• Solution: Provide specialized training for handling specific types of pharmaceuticals. Investing in the necessary equipment and ensuring adherence to handling protocols can streamline the transportation of specialty medications.

Addressing these challenges is critical to ensuring that vital medications safely reach their destinations, ultimately supporting global health systems and patient care. For shippers, this means investing in logistical technologies and adopting proper handling procedures.

How Are Pharmaceuticals Transported? &#; The Right Tech and Best Practices

Transporting pharmaceuticals is a critical process that employs several sophisticated technologies to ensure the products&#; safety and regulatory compliance. These technologies work together to maintain the integrity of sensitive medications throughout the shipping journey, addressing various logistical challenges shippers will face.

Here are the key technologies and best practices to consider:

1. Reefer Trailers
   • Function: Maintain necessary temperature conditions for sensitive medications during transit.
   • Best Practice: Equip trailers with advanced cooling systems that can be adjusted to meet the specific requirements of different pharmaceutical products. Regular maintenance and calibration of these cooling systems are essential to prevent any fluctuations that could compromise product quality.
   • Impact: Ensure medications remain effective and safe for use upon arrival, supporting optimal patient care.
2. GPS Tracking Devices
   • Function: Monitor the precise routes and timely delivery of shipments.
   • Best Practice: Utilize real-time location data to track cargo progress and ensure adherence to planned routes. Implement immediate actions for any deviations or delays to mitigate risks.
   • Impact: Provide visibility into shipment status, especially important for time-sensitive medications where delays can impact patient health.
3. Temperature Monitoring Systems
   • Function: Offer real-time data on internal trailer conditions.
   • Best Practice: Ensure systems monitor temperature, humidity, and other critical parameters. These systems should include alarms for any deviations, allowing for quick corrective actions. This real-time oversight helps prevent the spoilage of temperature-sensitive medications, maintaining their efficacy and safety.
   • Impact: Maintain medication efficacy and safety by preventing temperature-sensitive spoilage, ensuring patient safety and trust.
4. Visibility/Logistics Platforms
   • Function: Optimize routing and inventory management.
   • Best Practice: Use advanced algorithms to predict potential disruptions and suggest alternative routes. Efficiently manage inventory levels to ensure timely product availability and reduce waste.
   • Impact: Ensure timely delivery and availability of medications, minimizing the risk of stockouts and waste from expired products, thereby enhancing patient care.

How a Visibility Platform Enhances Pharmaceutical Shipments

A pharmaceutical visibility platform can play a crucial role in addressing the complexities of transportation for condition-sensitive products.

By providing real-time tracking and monitoring, these platforms offer several benefits:

1. Proactive Management

Proactive management in pharmaceutical transportation involves leveraging real-time data to monitor and control the shipping environment. By continuously tracking conditions such as temperature and humidity, shippers can ensure that pharmaceuticals remain within their required parameters throughout the journey. This real-time oversight allows for immediate adjustments if deviations occur, preventing spoilage or degradation of the products. Advanced monitoring systems and IoT devices play a crucial role in this process, providing shippers with the tools to maintain optimal conditions and mitigate risks proactively.

2. Following Through with Regulatory Compliance

Regulatory compliance is a cornerstone of pharmaceutical transportation. Automated logging and reporting features simplify adherence to stringent regulations set by bodies like the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA). These systems ensure that all necessary documentation is accurately maintained and readily available for inspections, significantly reducing the risk of costly violations. Compliance technologies also facilitate the audit process by providing a clear, verifiable record of the conditions and handling of pharmaceuticals during transit, thereby enhancing transparency and trust in the supply chain.

3. Enhancing Security

Enhanced security in pharmaceutical transport involves implementing advanced visibility tools to monitor the shipment&#;s integrity and location. Real-time tracking systems enable shippers to identify and respond swiftly to security breaches or route deviations. This level of oversight helps prevent theft, tampering, and other risks associated with high-value pharmaceuticals. Additionally, security measures such as tamper-evident seals and GPS tracking ensure that any unauthorized access or anomalies are detected immediately, safeguarding the shipment from potential threats.

4. Gaining Operational Efficiency

Operational efficiency is achieved through the integration of advanced analytics and logistical software. These tools optimize routing by predicting potential delays and identifying the most efficient paths, thus reducing transit times and costs. Predictive analytics help in managing inventory levels more effectively, ensuring that the right amount of product is available when needed. By streamlining operations, shippers can enhance the reliability and speed of pharmaceutical deliveries, ultimately improving service levels and reducing operational expenses.

5. Improving Communication Amongst Stakeholders

Effective stakeholder communication is crucial for maintaining a transparent and trustworthy pharmaceutical supply chain. Real-time updates provided by visibility platforms enhance communication between manufacturers, shippers, healthcare providers, and other stakeholders. This continuous flow of information ensures that all parties are informed about the shipment&#;s status, enabling timely interventions if issues arise. Improved communication fosters collaboration and trust among stakeholders, ensuring that pharmaceuticals reach their destinations safely and efficiently, thereby supporting patient care and public health.

Final Thoughts

For shippers looking to optimize their pharmaceutical transportation processes, consider integrating Descartes MacroPoint into your logistics strategy.

With its advanced real-time tracking and monitoring capabilities, Descartes MacroPoint provides unparalleled visibility and control over your shipments, ensuring that your pharmaceuticals arrive safely and on time.

Explore how Descartes MacroPoint can revolutionize your logistics operations and support the delivery of pharmaceuticals.

Visit Descartes MacroPoint and speak with a team member to get started today.

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