A study by the Mayo Clinic revealed that 7 out of 10 people in the U.S. take at least one prescription drug. And, while such drugs can provide vital, even life-saving, benefits, they can only have their intended effects when quality and potency is preserved from production to consumption. This means that great care must be taken throughout the supply chain to keep these drugs in safe, optimal conditions.
Pharmaceutical warehousing, therefore, is much more than the simple storage of products. It is an operation that preserves the integrity of drugs that affect the health and wellbeing of millions of Americans.
About Pharmaceutical Warehousing
Pharmaceuticals are stringently regulated by the Food and Drug Administration (FDA). The FDA’s regulatory standards for the industry are referred to as Current Good Manufacturing Practice (CGMPs; also known as “Good Manufacturing Practice” [GMP]) standards. These standards apply to warehouses, processes, and to the drugs themselves.
CGMPs related to warehousing include:
- Drugs must be stored to prevent contamination, and be positioned to allow for inspection and cleaning of the area.
- Each lot of drug products must be identified with a distinctive (and traceable) code, and the lot’s status must be identified (approved, quarantined, rejected).
- Written procedures must describe the distribution process for each drug. This includes procedures for recalls.
- Written procedures must describe the appropriate storage conditions for each drug.
A major pharmaceutical warehousing challenge involves these “appropriate storage conditions.” Different drugs can have vastly different requirements in terms of temperature, humidity, and lighting. The warehousing provider must ensure that the storage of each drug is in line with its specific requirements defined by the manufacturer. This can involve temperature-controlled warehousing and/or climate-controlled warehousing space – both of which require state-of-the-art control and monitoring equipment to keep the space within specific environmental parameters.
- Temperature-controlled space requires sophisticated control and monitoring equipment to ensure that the temperature of the facility stays within very specific parameters.
- Climate-controlled space regulates and monitors both the temperature and humidity of the space.
Selecting a Warehousing Partner
When looking for a logistics provider to handle a pharmaceutical warehousing operation, there are plenty of things to look for. In addition to the CGMPs listed above, a prospective logistics partner should be able to demonstrate the following:
- The facility should be clean and have adequate space for storage that also allows for maintenance, and inspection. It should have adequate lighting, ventilation, and environmental conditions for the drugs being stored. There should also be a quarantine area for drugs that have expired or otherwise can no longer be used.
- The facility’s security systems and processes – both inside and outside – must be able to prevent unauthorized entry and protect against theft.
- Drugs without specific storage requirements should be stored at “controlled room temperature” (according to the FDA).
- The provider’s inventory and WMS systems must be able to provide visibility into product location.
- The logistics partner must be able to provide written documentation of policies and procedures as well as inventories and distribution.
Kanban Logistics for Pharmaceutical Warehousing
Kanban offers climate-controlled storage space at our fully-RF-enabled warehouses in Plymouth and Rocky Mount, NC, with full traceability to the lot level. We are one of the very few logistics providers in eastern North Carolina that can provide these services for pharmaceutical products.
Kanban is registered with the FDA and adheres to all CGMP regulations and voluntarily undergoes audits from the FDA and from new clients during the onboarding process. Kanban is also ISO-9001:2015-certified which allows us to consistently deliver quality to our customers, while continually optimizing performance across the board.
To learn more about Kanban’s pharmaceutical industry solutions, contact us today.
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