Have you thought to yourself in recent times, “why are there so many commercials for drugs on television?” Aside from the fact that the United States is one of only two countries that permit advertising of prescription drugs directly to consumers, the market for pharmaceuticals is exploding! It is currently expanding at a rate of almost 12% annually, and it is anticipated that spending on COVID-19 will add nearly 160 billion dollars to the market by 2025. In spite of this growth, productivity in the warehousing and storage industry fell by 7.6% over the course of the previous year. A significant portion of this can be attributed to the growing pains that accompany businesses like pharmaceutical warehouses and distribution centers as they strive to expand their warehouse capacities, embrace emerging automation technologies, enhance employee safety, and adhere to stringent FDA and CGMP guidelines, amongst other requirements.
The Pharmaceutical Industry Faces Five Challenges in Terms of Warehousing and Distribution
Let’s take a look at the top five difficulties that the pharmaceutical logistics industry is working to overcome and manage right now.
1. Storage Facility Capacity
The requirements of the company at the time of construction are taken into consideration when designing and constructing many warehouses and distribution centers. Naturally, the pharmaceutical industry is constantly changing, and at the same time, the sector is witnessing significant expansion. More than 130 million people in the United States currently use prescription medication; this represents approximately 66% of the country, which is a higher percentage than it has ever been. Many of these people buy their medications online. Although some of this can be attributed to the pandemic (data from CVS reveals that online prescription orders increased by a factor of 1,000 during the early stages of the pandemic), it is unlikely that many people will revert back to their previous behaviors once the threat has passed.
Pharmaceutical warehousing companies are constantly looking to expand so that they can stock and store the enormous amount of product that they deal with. On the other hand, this can be challenging due to the fact that many medications have varying shelf lives, call for varying levels of temperature and humidity control, and have very specific instructions regarding their handling. What is the result? Warehouses for pharmaceutical products quickly reach their storage limits. What exactly are the capabilities of pharma warehouses and distribution centers? Many people may want to consider expanding vertically rather than horizontally in order to make the most efficient use of space. This can be accomplished by installing individualized storage solutions, such as pallet racks, industrial shelving, and other components that are designed to correspond with the configuration of the warehouse, which will result in an increase in both the capacity and efficiency of pharmaceutical storage.
2. Regulations Concerning the Product’s Safety
A pharmaceutical product is considered to be of high quality if it is “pure,” “correctly identified,” “effective,” and “safe to use,” respectively. Pharmaceutical storage requirements for quality control are becoming increasingly stringent in order to assist in ensuring that this is precisely what customers and patients can anticipate receiving. When it comes to warehousing, there are a great number of regulations that need to be considered and adhered to, including the following:
Temperature control. If temperatures outside of the required range are applied to medications, it is possible that the drugs will lose their effectiveness or even become harmful. A cool and dry environment is necessary for the majority of them, but some may even require freezing temperatures.
Regulation of the humidity. Condensation of moisture inside of packages can have an effect on the efficacy of the medication. There is a limit to how much these manufacturers can accomplish even though many of them put silica packs in bottles so that they can absorb moisture.
Ventilation. It is possible that pharmaceutical warehouses will need to make use of industrial fans, blowers, and dust collection systems in order to contain potentially hazardous byproducts while also controlling the indoor air quality. This will depend on the drugs that are being stored in the warehouse.
Light exposure. It is possible for the rays of the sun and other sources of light to alter the chemical structure of certain medications, which can result in a diminished efficacy or even adverse reactions in patients taking the medication.
Contamination prevention. Products have to be stored in areas that are designed to prevent them from becoming contaminated by other materials. The Over-the-Counter (OTC) products as well as biological materials like blood or plasma that are used in the production of pharmaceuticals are included in the FDA’s requirements for the prevention of contamination in pharmaceutical warehouses.
Many pharmaceutical warehouses are now utilizing technologies such as warehouse management systems in order to assist in ensuring that each medication is stored in the appropriate manner (WMS). A Warehouse Management System (WMS), the majority of which are cloud-based solutions, offers visibility into operations by keeping an eye on warehouse design, inventory tracking, picking and packing goods, receiving and putting away, shipping, labor management, yard and dock management, and reporting. In United States Title 21, part 205.50 subchapter C, you can learn more about the requirements that must be met by pharmaceutical warehouses.
3. The Capability of Tracing and Tracking Products
The FDA’s Current Good Manufacturing Process (CGMP) standards require, in addition to complying with regulations regarding safety, that careful track be kept of the locations of individual items within the warehouse. The requirements for pharmaceutical warehousing require that operators keep written procedures that detail the storage conditions for each drug that they are responsible for storing. In addition, every drug has to have a special code that can be tracked back to it and tells what the status of the lot is (e.g., approved, quarantined, or rejected). In addition, it is necessary to have written procedures that describe the process of distribution for each drug, including any necessary recalls.
Other CGMPs in the pharmaceutical industry state that pharmaceutical warehousing are required to check every product that comes in from suppliers to ensure that it is in compliance with the following requirements:
From a reliable source that is included in the inventory database of the company.
Marked with a Unique Identification Number (UIN) that is clearly visible and is different from the lot number that the supplier has assigned, and that they are labeled correctly (for example, current, expired, etc.) with all of the required information
Damage-free and devoid of any flaws.
Until quality control tests are completed, it will remain in quarantine (pharma warehouse managers should have a designated area for testing raw materials to confirm they meet all required standards; another section should be set aside for any materials that fail these tests).
stored according to their classification whenever possible, and that dangerous or addictive substances or chemicals are kept apart in a secure location to which only authorized personnel have access.
Once again, many pharmaceutical warehouses are turning to a modern warehouse management system (WMS) in order to manage product traceability and tracking. When a smart WMS is in place, pharma warehousing operators are able to control and monitor inventory, gaining a 360-degree view of the product in real-time, from the moment a product enters a warehouse until it is transported out to stores or end-users. This is possible because of the WMS’s ability to provide real-time data. They are able to record changes in inventory, anticipate needs for additional inventory, and do much more thanks to the system. Additionally, it helps improve pharma warehousing standards, which in turn helps support product traceability and accelerates response times in the event of a product recall.
4. Protection of Employees
The warehouse is a potentially hazardous environment, and one of the most significant challenges that the pharmaceutical industry faces today is ensuring the safety of its workforce. Accidents that occur on docks or involve forklifts, conveyors, the manual lifting of materials, or the storage of materials can lead to serious injuries or even fatalities. The loading dock is the scene of twenty-five percent of all industrial accidents, and forklifts are involved in nearly thirty-five thousand serious accidents each year.
Accidents that occur in pharmaceutical warehouses have repercussions for the company itself, in addition to having a devastating effect on those injured and the families of those injured. Warehouse accidents account for 95 million lost workdays every year, and accidents result in a loss of productivity, claims for worker compensation, decreased employee morale, and possible OSHA fines. Warehouse accidents account for 95 million lost workdays every year. Dock alerts, lighting, and safety gates are just some of the potential safety features that pharmaceutical companies should think about installing in their warehouses. Other potential safety features include rack netting, end guards, and pallet support bars. This will help pharmaceutical companies keep the number of accidents that occur in their warehouses to a minimum while also ensuring the safety of their employees. You can get a copy of our safety checklist for the warehouse here.
5. Computers and other forms of technology
Automation is at the forefront of the digital transformation that is on the verge of radically altering warehousing, distribution, and fulfillment, all of which are poised to be irrevocably transformed. The majority of today’s pharmaceutical warehouses are adopting fully automated warehouse solutions in order to meet the stringent guidelines established by the FDA and to improve the overall efficiency of their operations. Automating a warehouse is the first step toward creating a “smart warehouse,” which eliminates the need for human interaction while providing real-time data that can be used for quality control.
Putting things away and getting them out again is one of the primary advantages of using automation in pharmaceutical warehouses. This can be accomplished with storage/retrieval machines (S/RMs), which do the work that standard fork-trucks used to do, and with articulating-arm robots, which are machines that have rotary joints (such as a trunk, shoulder, upper arm, forearm, and wrist) and are used for case picking activities that were previously performed by humans. This not only makes working conditions safer for employees but also makes it much less likely that they will steal from the company (many drugs yield high profits at low volumes, making them a target for unscrupulous employees). S/RMs and articulating robots are frequently paired with self-driving pallet trucks, which replace manual forklift moves from dock to storage, and small bin automated storage systems, which carry items along conveyor belts from the sorting area to the picking area. In addition, S/RMs and articulating robots are frequently paired with small bin automated storage systems, which carry items along conveyor belts from the sorting area to
Spimaco, a pharmaceutical company based in Saudi Arabia, is a good example of automation in action. A short time ago, the facility was a crowded, laborious manual operation that was struggling. The company made the decision to modernize by automating more processes, and as a result, they now have a state-of-the-art warehouse that is capable of palletizing, picking, automated storage and retrieval, and the shipment of pharmaceutical goods that are in full compliance with regulations. It has more than 5,000 storage spaces, hundreds of meters of conveyors for cases and pallets, over 30 automated shuttle vehicles, and two robots that can stack pallets. Spimaco now has full inventory control, high-quality track-and-trace programs, the ability to handle extremely delicate products that are governed by strict industry rules and regulations, and its throughput rates have almost doubled as a result of Spimaco’s automation.
Because the implementation of new technologies can be expensive, it is essential for pharmaceutical warehouses and distribution centers to have a solid understanding of the requirements they have as well as the objectives they hope to achieve with any new pharmaceutical technologies. Each of these technologies is unique and comes with its own set of features. You should consider the benefits and drawbacks, and ensure that you will see a healthy return on investment in the shortest amount of time possible.
How SSE Supports the Needs of the Pharmaceutical Storage Industry
In the pharmaceutical industry, warehousing isn’t always the easiest thing to do. Is one or more of these distribution obstacles putting a strain on your pharmaceutical company? The experts at Southern States Enterprises (SSE) want to assist you with your warehousing needs if your facility is located in either Florida or South Georgia. The experts at Southern States Enterprises (SSE) want to assist you with your warehousing needs if your facility is situated in either Florida or South Georgia. Southern States Enterprises has been the area’s go-to supplier of motive power, docks and doors, industrial pallet rack, pallet storage systems, and warehouse equipment for well over 20 years, earning the company the reputation as the most trusted brand in each of those categories.
We are familiar with the process of vertically expanding your facility, which will enable you to reduce costs, boost operational and employee productivity, and improve efficiency. We are also familiar with how to make safety a top priority and are familiar with the specific requirements necessary to maintain the safety and effectiveness of your racks, docks, and doors. Our field service technicians will also keep your facility operating smoothly and safely at the lowest possible cost through a planned maintenance and repair schedule using a warehouse safety checklist. This service will be provided in accordance with a warehouse safety checklist. We are able to provide assistance, make product recommendations, and locate the appropriate hardware for you when it comes time to purchase a new component, a replacement component, or upgrade your technology.