4 Strict Rules In Pharmaceutical Logistics
The worldwide demand for pharmaceutical products is at an all-time high. With the global pharmaceutical market growing every year, and a USD$1.27 trillion value at the end of 2020, the need for bigger, faster, and more efficient distribution methods also becomes increasingly pressing.
But here’s the challenge: pharmaceutical products are more delicate. For example, vaccines that require a cold chain—which means they must be kept at low temperatures at all times—or they would spoil.
Most pharmaceutical products, especially medicines, are highly degradable and require specific storage conditions. For logistic companies to qualify as service providers in the pharmaceutical supply chain, there are standards and regulations they must first comply with.
The Importance Of Government Regulations
By enforcing rules and regulations, government regulatory bodies, such as the Food and Drug Administration (FDA) help to maintain the quality of pharmaceutical products in the market from production to distribution.
These regulations help to protect consumers against products that are substandard, counterfeit, or are unsafe for medical use. This is also why consumers are always advised to only trust companies that are compliant with the guidelines set out by their country’s regulatory bodies.
When it comes to logistics, aside from transportation, warehousing facilities are also a critical aspect. Regulations apply to both transportation and storage. Ideally, the facilities and vehicles used are exclusive for pharmaceutical products only. This helps to avoid potential contamination and makes the process more efficient for its intended purpose.
Here are the strictest and most important rules that pharmaceutical logistics must adhere to:
- Temperature Control
A lot of pharmaceutical products, including tools like syringes and needles, require specific temperatures for storage and transportation. They often require refrigeration, freezing, and insulation. Hence the need for controlled room temperatures.
Some products can be damaged by as little as a 2-degree temperature fluctuation. For such pharmaceutical products, storage and handling are stricter, and they often require a special facility of their own. These facilities cannot afford a break in temperature levels, which is also why pharmaceutical storage services can be expensive.
In warehouses, it’s easy to maintain the recommended temperatures just by using air-conditioners. However, it gets more challenging during transportation. Standard trucks used in delivery, when running, usually heat up to extremely high temperatures, especially in sunny weather. Another challenge is getting caught up in everyday traffic snarl-ups, which can be a problem for products that require timely delivery.
For smaller drug manufacturers, hiring reefer trucks for pharmaceutical deliveries is the best option. These specialized vehicles are like refrigerated trailers. They’re fitted with temperature control systems to ensure all pharmaceutical products in transit stay within their required temperature range without disruption.
- Hygiene Maintenance
Contamination can be detrimental to the quality of pharmaceutical products. This is a no-brainer as medical products are meant to help address health issues, and any infiltration from unwanted microorganisms just defeats the purpose entirely.
To avoid this, high-level maintenance is a must for both the facilities and the vehicles. But aside from disinfecting storage areas and vehicles, strategic processes should be in place at all levels of product handling. All staff members should be trained and equipped for this. In the same manner, tools or machinery that come into contact with the products should also be maintained hygienic at all times.
Inside the facilities, humidity levels should be kept at a minimum. Humid conditions and stagnant air are conducive to the growth of molds, which can contaminate the area and even cause damages.
It’s also important to remember that health authorities often carry out impromptu inspections of facilities that produce or house pharmaceutical products. If they see any signs of contamination, the facility, or part of it, may be suspended or even shut down.
- Record-Keeping
In light of the vital storage parameters discussed above, accurate documentation of every important detail of a product batch is a must as it goes through the supply chain. Mistakes in record-keeping can cause unnecessary waste of time and money. But more importantly, proper documentation helps to control and monitor quality and compliance at all levels.
Central management systems are ideally used in standard record-keeping. These systems also make it easier to retrieve information and manage documents.
But aside from inventory purposes, these records are also requested by health officials during their inspection rounds.
- Security
Pharmaceutical supplies are considered high-value products. They’re prone to threats like cargo theft, hijacking, and route diversions. Hence, authorities advise transporters to provide maximum security for products in transit. Getting them to their destination on time may also help to save lives.
Security also applies to the handling of the products. For example, it’s crucial in the maintenance of required temperatures. If the products are subjected to any unintended exposure during the process because of non-secure packaging or handling, the cold chain will be broken and the products will be spoiled or damaged.
Conclusion
Because of its delicate nature, the pharmaceutical supply chain requires reliable logistic services that can maintain the demands of its strict rules. A weak link in the supply chain will disrupt not only the distribution process but the quality of the pharmaceutical products too.
The good news is there are pharmaceutical logistic companies that have the expertise for this already. For smaller manufacturers and distributors that do not have their own, it’s best to just leave the storage and transportation services to the experts to make sure the integrity of the supply chain is maintained at all levels.