Pharmaceutical Warehousing Requirements
Pharmaceuticals Help Keep Us Healthy, But How Do You Keep Pharmaceuticals Healthy?
More than 131 million people use prescription drugs, which is 66% of all adults in North America according to the Georgetown Health Policy Institute. Many people depend on these drugs to manage severe or chronic conditions and maintain a certain quality of life.
The supply chain of prescription drugs and other pharmaceutical products must meet specific requirements. If a drug loses its quality or potency at some point between production and consumption, it offers no medicinal value.
Warehousing is a crucial component of the pharmaceutical supply chain management that contributes significantly to the wellbeing of millions of people.
In Canada, pharmaceuticals are regulated by the Health Products and Food Branch (HPFD) of Health Canada. In the United Sates, the Food and Drug Administration (FDA) regulates pharmaceuticals.
There are numerous regulatory standards that apply to pharmaceutical warehousing, products, and processes through the Good Manufacturing Practice (GMF) standards.
Included are several pharmaceutical warehousing requirements in the GMF standards:
- Warehouses must store drugs in a manner to prevent contamination, and that allows for thorough inspection and cleaning of the area.
- Each drug lot must have a unique and traceable code to allow for lot identification and lot status identification (approved, quarantined, rejected.)
- Each drug in the warehouse must have written procedures that describe the processes for distribution and recalls.
- The written procedures of each drug must describe appropriate storage conditions.
Appropriate storage requirements present unique challenges to pharmaceutical warehouses. Each drug has individual storage requirements in terms of temperature, lighting, and humidity. The warehouse must follow the drug manufacturer’s storage requirements to the letter.
Meeting storage requirements often involves setting and monitoring the environmental parameters of a storage section’s temperature- and climate control.
Temperature control involves controlling and monitoring the temperature of the facility.
Climate control refers to the regulation of a storage unit’s temperature and humidity.
What to Look for in a Warehouse Partner
A pharmaceutical warehousing provider should not only meet GMF standards, but the facility should also meet the following requirements:
- The warehouse should be sterile with enough space for storage, maintenance, and inspection.
- The facility should have sufficient ventilation and lighting.
- The facility should have a dedicated quarantine area for drugs that are no longer usable.
- The warehouse should have indoor and outdoor security systems in place to prevent unauthorized entry and theft.
- The warehouse should be able to store drugs without specific storage requirements at room temperature.
- The warehouse partner should be able to provide the client with written documentation of policies, distribution, inventory, and procedures.
Brimich Logistics for Pharmaceutical Warehousing
Brimich Logistics in Ontario provides a wide range of warehousing and value-added services. Our facilities are HACCP-compliant, and SQF certified. The benefits of Brimich Logistics include:
- Real-time data on inventory
- Efficient warehouse staff
- Facilities to store pharmaceutical drugs according to manufacturer instructions
- Industry-standard safeguarding against drug contamination
Brimich Logistics provides pharmaceutical clients in Ontario with responsive and reliable warehousing solutions. We are ready to assist you with your pharmaceutical warehousing solutions today. To learn more about our warehousing, logistics, value-added, and transportation services, contact us today.