According to a Mayo Clinic research, seven out of ten persons in the United States use at least one prescription medicine. And, while such pharmaceuticals can be life-saving, their intended effects can only be achieved if quality and potency are maintained from creation to use. This implies that extreme caution must be exercised throughout the supply chain to ensure that these medications remain safe and effective.
As a result, pharmaceutical warehousing encompasses far more than just product storage. It’s a mission to protect the integrity of pharmaceuticals that have a significant impact on the health and well-being of millions of Americans.
Pharmaceutical Warehousing is a term that refers to the storage of pharmaceuticals.
The Food and Drug Administration (FDA) regulates pharmaceuticals quite strictly (FDA). Current Good Manufacturing Practice (CGMPs; sometimes known as “Good Manufacturing Practice” [GMP]) standards are the FDA’s regulatory requirements for the industry. These regulations include warehouses, procedures, and the medications themselves.
The following CGMPs apply to warehousing:
- Drugs must be stored in a way that prevents contamination, and they must be placed in such a way that examination and cleaning of the area is possible.
- Each lot of drug items must be recognized by a unique (and traceable) code, as well as the lot’s state (approved, quarantined, rejected).
- Each drug’s distribution process must be described in writing. This covers recall processes.
- The proper storage conditions for each medicine must be described in writing.
These “proper storage conditions” constitute a key pharmaceutical warehousing problem. In terms of temperature, humidity, and illumination, various medications may have quite varied requirements. The warehouse provider must verify that each medicine is stored in accordance with the manufacturer’s specified specifications. This can include temperature-controlled warehousing and/or climate-controlled warehousing, both of which need cutting-edge control and monitoring systems to maintain specified environmental conditions.
- To keep the temperature of a temperature-controlled area within extremely exact parameters, sophisticated control and monitoring technology is required.
- The temperature and humidity of a climate-controlled room are managed and monitored.
Choosing a Warehousing Company
There are several factors to look for when selecting a logistics supplier to handle a pharmaceutical storage business. A potential logistics partner should be able to show the following in addition to the CGMPs specified above:
The building should be clean and have enough storage space to accommodate maintenance and inspections. For the medications being kept, it should have proper illumination, ventilation, and climatic conditions. A quarantine space for pharmaceuticals that have expired or can no longer be utilized should also be provided.
- The inner and exterior security systems and operations of the facility must be able to prevent unlawful entrance and theft.
- Drugs that don’t require special storage should be kept at “controlled room temperature” (according to the FDA).
- The inventory and warehouse management systems of the provider must be able to give visibility into product location.
- Written documentation of rules and processes, as well as inventories and distribution, must be provided by the logistics partner.
- Pharmaceutical Warehousing using Kanban Logistics
At our completely RF-enabled warehouses in Plymouth and Rocky Mount, NC, Kanban provides climate-controlled storage space with full traceability down to the lot level. We are one of the few logistics companies in eastern North Carolina that can offer these services for pharmaceuticals.
Kanban is FDA-registered, follows all CGMP rules, and willingly submits to FDA and new client audits as part of the onboarding process. Kanban is also ISO-9001:2015 certified, allowing us to constantly offer high-quality service to our clients while continuously improving overall performance.