The Rules for Shipping Pharmaceuticals

We&#;ve already written about the best practices for shipping medical equipment, which requires careful planning, coordination, and handling due to the sensitivity and value of the commodity. Much of the same is true when shipping for the pharmaceutical industry, which is obviously very much tied to the healthcare industry. It aids in the production and distribution of raw materials and the chemical compounds that are necessary for many of the ingredients used for an array of products like creams, gels, capsules, and other cosmetics, among other things.

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Pharmaceutical companies also ship essential everyday medicines with familiar brands found over-the-counter and through prescription, as well as a whole line of crucial vaccines. Most pharmaceutical shipments require stringent cold chain management, as most products are temperature-controlled. Much like the healthcare and medical industries, the pharmaceutical industry is highly regulated; products shipped must be handled properly to reduce the risks of spoilage or load rejection upon delivery.

The global pandemic has highlighted just how crucial it is for pharmaceutical products to get replenished immediately to ensure the sick and vulnerable of our society get the essential treatment they need to improve their wellness. Pharmaceutical companies should partner with a transportation provider with decades of experience hauling exclusively for the healthcare and wellness industry. This article looks at some best practices and rules for shipping pharmaceutical goods.

What is the Cold Chain?&#;

Shippers who move sensitive temperature-controlled products operate in what the industry refers to as a cold chain. The organized handling and coordinated movement of refrigerated products with controlled points of custody ensure temperature variances do not exceed levels that might jeopardize the integrity or quality of the product. In other words, the cold chain serves as a checkpoint that ensures the correct temperature remains constant at every single touch point within the logistics of a shipment.

Suppose a batch of medicines is ready to be shipped from a major pharmaceutical company. In that case, the distribution center will have a temperature-controlled warehouse facility for storing the product before arranged transport arrives to move it to the next destination. A properly functioning cold chain would usually have temperature safeguards in the facility to validate the commodity&#;s correct temperature from the offset.

Once a refrigerated truck arrives to haul the product to the next destination, a worker would likely check to verify if the truck&#;s reefer setting is set to the correct temperature for transporting the goods to the next destination. The 3PL partner will likely monitor this situation, as well. Once the product is loaded onto the truck, the carrier and operations personnel will ensure the reefer temperature is at the correct setting. At the same time, the driver transports the commodity to the next delivery point. At delivery, the receiver will check to verify the product did not endure any temperature variances during transportation. This is a high-level explanation of a cold chain.

What is Pharmaceutical Cold Chain Management?

Cold chain management is the administrative side of ensuring that all phases of a product&#;s movement through storage, transportation, and delivery adhere to the safe temperature levels and regulatory requirements necessary for moving pharmaceutical supplies. Shipping managers usually require that their transportation providers offer technologies that offer real-time visibility on all shipments. This level of transparency helps mitigate the chances of temperature variances that can cause spoilage, product rejection, and other serious financial damages that may occur if a temperature-sensitive commodity gets transported at the wrong temperature.

The Difference Between Cold Chain and Supply Chain

The biggest difference between a traditional supply chain and a cold chain is the amount of paperwork and regular monitoring required for shipping a load. Thermally shipped products need special care and handling. Shippers and logistics partners generally spend more time worrying about the status of temperature-controlled freight versus commodities that can be transported in a regular dry van. Cold chain shipments need much more communication between warehouse personnel, carrier partners, brokers, truck drivers, and receivers. Centralizing these touchpoints will help ensure shippers know the status of their loads at all times.

Equipment Needed to Ship Pharmaceutical Products

For starters, it depends on the commodity and whether the product is hazardous or temperature-controlled. Not all pharmaceutical products require reefers or refrigerated transportation; however, when shipping time-sensitive and perishable goods, the carrier must have a truck that accommodates the proper handling of the commodity. Some products, like steroids, vaccines, insulin, chemotherapy medicines, and topical creams, have specific storage requirements that require refrigerated transport. Pharmaceutical shippers often look to partner with carriers that offer a range of services and equipment to meet the individual needs of their customers.

What Regulations Need to be Followed to Ship Pharmaceuticals? 

The FDA lists a set of regulations for the current model handling of manufactured pharmaceutical goods, as well as proper delivery practices needed. However, this recommendation is just an overview and will depend on the specific needs guided by the individual shipper moving the goods. Ideally, pharmaceutical shippers will want to partner with a transportation provider that has deep knowledge and experience working with the medical and pharmaceutical industries.

What Happens if Pharmaceutical Products are not Shipped Correctly?

Pharmaceutical products risk being exposed to the elements if shipped incorrectly. A loading delay, a temperature excursion during transportation, or perhaps intense exposure to sunlight may cause harm to the products. The longer that pharmaceutical goods are left sitting in a supply chain, the greater the control problem and likelihood that the product might get damaged. Most pharmaceutical shippers have detailed cold chain labels sent as manifests to the carrier partner to ensure proper handling throughout the product&#;s distribution. Full visibility and tracking options help alleviate potential issues exposing pharmaceutical commodities to unsuitable environments. 3PL partners are usually experienced with the proper handling of a variety of commodities and can help minimize the risk of shipping high-value cargo with sensitive requirements.

The Threat of Cargo Theft in the Pharmaceutical Industry

Though not as common as other roadside incidents, such as accidents, cargo theft is a problem that occurs throughout the world. Especially when it comes to shipping highly valued commodities like pharmaceuticals. Drugs are high-valued products, and they can be very lucrative for criminal enterprises looking to find a commodity that is easier to sell and unload, unlike a truckload of used tires. The pharmaceutical industry safeguards against theft by partnering with transportation providers that offer GPS tracking technologies and APIs that connect seamlessly to existing TMS software. This interoperability gives shippers unprecedented visibility to ensure each shipment runs as smoothly as possible.

Wicker Park makes Shipping Pharmaceutical Goods Easy

Shipping pharmaceutical goods shouldn&#;t be a hard pill to swallow. The best way to ensure proper handling of any pharmaceutical shipments is to find a logistics company that provides customizable services that fulfill your company&#;s unique needs. Shipping time-sensitive commodities like medical equipment and pharmaceutical goods has never been easier when shipping with Wicker Park Logistics. Wicker Park Logistics offers cutting-edge technologies and a dedicated team of experts with deep knowledge in handling the specific needs of shippers in the pharmaceutical industry. That&#;s why hundreds of pharmaceutical companies rely on Wicker Park Logistics to help optimize their cold chain, ensuring the proper handling of their time-sensitive goods and making sure that each delivery is on-time and in full. Contact Wicker Park Logistics today!

The pharmaceutical industry has made great strides in the past few decades with the development of new medications and technologies for the treatment of different diseases. When it comes to packaging and shipping of pharmaceutical products, the considerations for supply chain are elevated along the way. Pharmaceutical transportation must be efficient and compliant with stringent safety standards to ensure the quality of products is not compromised. 

Transporting Medications

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Many pharmaceutical companies outsource their packaging and shipping through third party organizations, necessitating a high degree of coordination between parties to maintain compliance with safety standards. Pharmaceutical products encompass a diverse range of commodities, from pills and capsules to tissue samples and everything in between, the handling specifications are just as varied as the number of products. Things such as temperature, humidity, light, and even vibration can cause irreparable damage to sensitive products, which can be expensive, and sometimes fatal to the patients that will receive the medications. Pharmaceutical shipping is among the most difficult supply chain components to manage, and transportation of products must be tightly controlled and considered. Common methods of transportation include ground, train, air, and sea transit. Carriers frequently favor road transit in specially outfitted reefer trucks, due to the need for rigorous monitoring of conditions. Air transportation is faster but is less popular due to a lack of common standards and transparency. Shipping pharmaceuticals by train or sea in dedicated refrigerated containers is also a common method, due to the tightly controlled shipping industry and distribution chain already in place in these areas.

Temperature Monitoring and Control

With 7 in 10 of the top pharmaceuticals in the United States requiring temperature-controlled shipping, the emphasis on cold chain logistics has never been higher. A cold chain is a type of supply chain that deals with transporting perishable, temperature-sensitive goods at their optimal temperature range to prevent spoilage. Pharma transport is particularly difficult, as a change in temperature as small as two degrees Fahrenheit might be enough to spoil a product. Obviously, the longer the distance between manufacturing facility and destination, the more legs the shipment must travel, thereby introducing numerous potential variables. Ensuring optimal temperature control depends on multiple factors, such as type of cargo, method of packaging, required temperature and humidity levels, size of shipment, duration of transit, and environmental conditions. There are many types of temperature monitoring devices and software available on the market, as well as advances in packaging materials and technologies that have been developed to address the need for compliant shipping conditions. Container temperature can be monitored remotely and constantly to track and adjust any temperature fluctuations.

Regulatory Requirements

Because the pharmaceutical industry is vital and delicate, there are numerous regulations and requirements set by different government or regulatory agencies to protect the safety of shipping and storage of products. Standards have been set by all parties involved regarding temperature, packaging, handling, and timing of shipments, as well as documentation during travel. Good Distribution Practices (GDP) is a quality assurance standard for warehouse and distribution centers dedicated to the handling of medicines and medical supplies. The certification ensures that consistent quality management practices are in place throughout the entirety of the supply chain process, from the delivery of raw materials to the manufacturing plants, to the eventual shipment of finished drugs to the wholesale distributor or buyer. GDP is based in the European Union, but GDP standards are internationally recognized. The US Food and Drug Administration developed standards for the manufacturing, storage, and distribution of food and pharmaceutical items under regulations created in . These standards were updated in to address updates from the Food Safety Modernization Act (FSMA). The FDA provides specific information under Title 21 of the Code of Federal Regulations (CFR) as to the additional regulations surrounding the handling and transportation of any prescription medications.

Proper documentation of handling of medicinal products is a crucial part of maintaining compliance with regulatory standards. Everything from transportation and storage to site inspections and personnel training needs to be properly documented every step of the way. The Drug Supply Chain Security Act (DSCSA) that was passed into law in gives the FDA greater authority with tracking and regulating compounded drugs. The main priority of this law was to keep patients safe from harmful or counterfeit drugs, while offering a secure way to track the pharmaceutical supply chain from start to finish. Even though the law was passed in , full DSCSA implementation was not set to occur until . Full implementation includes additional requirements for product tracing at the package level, affecting stops along the drug lifecycle. At MPI, we provide a simple solution that can help you prepare for the DSCSA compliance deadline. Our Pak-EDGE® barcode labeling software provides accurate and efficient product labeling with serialization to help you meet DSCSA requirements at the package level. The latest version of this software includes more design features, as well as an enhanced label template that can be used to clearly label products with all the required information for tracking and tracing. 

Supply Chain Visibility and Traceability

Modern technology plays an integral role in the monitoring of pharmaceutical transportation. Having real time visibility to the conditions and location of such delicate and sensitive products is important for stakeholders to be able to react quickly to any deviations. Continuous GPS tracking, along with data loggers or Bluetooth temperature trackers are some of the most common hardware used. Many software systems involved in the manufacturing and shipping of pharma products have integrated functionalities that allow users to receive real time data from shipments. With so many players involved in pharmaceutical distribution and creation, seamless integration of data is key to an efficient supply chain. 

Risk Management and Security

Pharmaceutical shipments are not without risk. Apart from the risks of product damage due to poor regulation of shipping and storage conditions, cargo theft is also a concern. Stolen pharmaceuticals and prescription drugs often find their way into the illegal market. Since most warehouses are tightly secured, and only accessible by authorized personnel, most thefts happen during transit. Implementation of appropriate security protocols are important for the safeguarding of controlled substances. Many pharmaceutical manufacturers contract with third party logistics providers and security agencies to establish secure handling procedures. Utilizing total visibility solutions helps to safeguard valuable pharma cargo throughout the process of transportation and distribution.

Packaging and Labeling

Proper packaging is paramount to ensuring the safety and viability of sensitive pharmaceutical products. Passive and active cooling technologies are examples of storage innovations developed to keep products at their needed temperature. Actual packaging of the pharmaceuticals themselves is an important part of ensuring that the products get to their  destination unscathed. Choosing the right packaging solution is the first step to delivering an undamaged product. Beyond the packaging itself, appropriate labeling throughout the duration of manufacturing, storing, and transporting pharmaceutical products is necessitated under law to mitigate risk and reduce the potential for confusion. Anyone who works in a medical field knows that labeling medications is a cornerstone of training for one reason: ensuring patient safety. Proper packaging and labeling are important for ensuring the protection of vulnerable pharmaceutical products and medications from both temperature and environmental concerns, as well as the risk of tampering or counterfeiting. 

Medical Packaging Inc., LLC (MPI)

MPI integrates into the pharmaceutical supply chain by providing comprehensive packaging solutions to a wide range of clients in a variety of market segments. We serve manufacturers, wholesalers, repackagers, and many other types of healthcare clients. Our full line of medical packaging products include unit dose packaging machines and barcode labelers for oral solid medications, oral liquid medications, syringes, and more. We also offer a powerful yet easy-to-use software utility for barcode and label design, facilitating inventory organization and helping to reduce medication errors. To learn more about our medication packaging and labeling products, MPI-certified consumable materials, and the custom solutions we provide, contact our representatives today!

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