Pharmaceuticals are good for our health. But how do you keep them healthy?
According to Georgetown Health Policy Institute, 66% of adults in North America use prescription drugs. This is more than 131 million people. These drugs are used by many people to treat severe or chronic conditions, and maintain a certain standard of living.
Specific requirements must be met in order to ensure that prescription drugs and other pharmaceutical products are supplied. It is not worth the medicinal value of a drug if it loses its potency or quality between production and consumption.
Warehousing is an important component of the supply chain management of pharmaceuticals that has a significant impact on the well-being of millions.
The Health Products and Food Branch of Health Canada (HPFD), regulates pharmaceuticals in Canada. The United States Food and Drug Administration (FDA), regulates pharmaceuticals.
Many regulatory standards apply to pharmaceutical warehousing and products.
There are many requirements for pharmaceutical warehousing in the GMF standard:
Warehouses should be able to store drugs in a way that prevents contamination.
This allows for inspection and cleaning.
To allow lot identification and lot status identification (approved or rejected), each drug lot must be assigned a unique, traceable code.
Written procedures must be created for each drug stored in the warehouse. These procedures should outline the distribution and recall processes.
Each drug’s written instructions must include appropriate storage conditions.
Pharmaceutical warehouses face unique challenges when it comes to storing the right drugs. Every drug has its own storage requirements, including temperature, lighting, humidity. The storage requirements of the drug manufacturer must be followed to the letter by the warehouse.
Setting and monitoring environmental parameters for storage sections is often necessary to meet storage requirements.
Temperature control is the process of controlling and monitoring temperature in a facility.
Climate control is the regulation of temperature and humidity in a storage unit.
What to look for in a Warehouse Partner
The GMF standards for pharmaceutical warehousing providers should not be the only thing that should be met. However, the facility must also comply with the following requirements:
The warehouse must be clean and have enough space to store, maintain, and inspect.
You should ensure that the facility has adequate ventilation and lighting.
A designated quarantine area should be provided for any drugs that are not usable.
To prevent theft and unauthorized entry, the warehouse should have both indoor and outdoor security systems.
The warehouse should be capable of storing drugs at room temperature without any special storage requirements.
Warehouse partners should be able provide written documentation to clients regarding policies, distribution, inventory, procedures, and other details.
For more Pharmaceutical warehousing information look here.
Location The location of warehousing relative to the nearest airport, seaport, and main roads.
Equipment: Can the equipment be used to meet your requirements and store your products at the temperature you require?
Third party logistics: “If there are several logistics service providers, it is likely that you will have higher fixed costs.”
Licenses If products are stored outside of the EU, you will need to have a variety of licenses, including those for GMP and pharmaceutical GDP.
Regulatory Landscape “Regulations can be very country-specific. There is EU legislation, and there are different regulations within each country. There are often very different legal policies depending on the location of the warehouse.
“We spend a lot of time in advance deciding if the facility we choose has the ability to meet all the regulatory requirements.”
Warehouse temperatures must be monitored and controlled in order to ensure good warehousing practices and distribution. Temperature maps should be done on warehouses to assess risk areas and determine temperature distribution.
If temperatures rise beyond the product label’s storage requirements, it is important to take appropriate action.