For essential medicines to be available to patients, it’s necessary to create reliable supply chains and pharmaceutical warehousing strategies that transport these pharmaceutical products to healthcare providers. That includes getting medications into the hands of qualified pharmacists, hospitals, and doctors’ offices. Therefore, it’s imperative that manufacturers carefully create supply chain and warehousing practices supervised by regulators.
Slight oversights in warehousing or supply chain management can make medications unavailable for patients or cause pharmaceutical products to become degraded or ineffective. Unavailable or inadequate medicines can cause patients to suffer and even result in large-scale public health crises. As a result, do not overlook the life-threatening nature of supply chain and warehousing errors, and regulators must take specific steps to prevent these catastrophic outcomes.
That’s why manufacturers and supply chain professionals must take steps to uphold quality assurance standards and keep patients safe. It’s also why regulatory bodies like the Food and Drug Administration (FDA) oversee pharmaceutical companies’ actions in the interest of patients. However, many people still need to learn about critical standards and requirements of pharmaceutical warehousing and supply chain management, so let’s explore the essential aspects of this vital field.
Maintaining Appropriate Warehouse Storage Conditions
According to Dickson Data, pharmaceutical companies must ensure storing their products in conditions that don’t affect their quality or efficacy. Those conditions can vary depending on the products. For example, many medications require storage within specific temperature ranges.
These medications require transportation and warehousing thoughtfully to prevent them from degrading. Controlling storage temperatures is among the most significant challenges regarding pharmaceutical warehousing and supply chain management. That’s because companies must often invest in expensive cooling equipment that keeps temperatures reliably stable.
Not only are these cooling and refrigeration systems expensive to buy and maintain, but require monitoring so that any instrumental error is detected as soon as possible. Moreover, some pharmaceutical products require low storage temperatures that commercial refrigerators or freezers can’t maintain for long periods. In these cases, implement alternative cooling systems to keep temperatures sufficiently low.
An example is the Pfizer COVID-19 vaccine, which requires storage at ultra-low temperatures. To accomplish this, Pfizer designed their own customized shipping containers that use dry ice to keep internal temperatures sufficiently low throughout transport.
Pharmaceutical companies must sometimes consider other storage conditions, such as humidity. Fluctuations in humidity can cause products to be more susceptible to airborne pathogens, microorganisms, and mold. In some cases, it could even affect the chemical structure of certain medications.
Companies must also consider the placement of storage units in warehouses and ensure order in an area with proper ventilation and airflow. In addition, the inventory load of storage facilities requires tracing since that can influence storage conditions. Finally, all staff should be well-trained in warehousing best practices, such as limiting the presence of possible contaminants like food and drinks in warehouses.
Setting Up Environmental Monitoring Systems
Just as important as setting up secure warehouse storage conditions is monitoring those conditions so that management becomes aware when exposing products to improper temperatures. To this end, companies use tools like data loggers to track storage temperatures. Data loggers are small electronic devices that collect and record environmental data from their surroundings, such as temperature, humidity, and differential pressure.
Data loggers record temperatures regularly and typically record this on their internal memory. The data can then be securely transferred to computers or cloud storage systems and analyzed using software solutions. The data can also be formatted and submitted to regulators, often necessary for pharmaceutical companies shipping or storing temperature-sensitive products.
Data analysis software can also use powerful machine-learning algorithms to detect essential patterns or discrepancies in storage temperatures. That allows leadership to take action early and prevent those products from being administered to patients. In some cases, a product recall will be necessary.
The possibility of supply chain problems or even a recall illustrates why it’s essential for all products to be carefully labeled and tracked, often referred to as traceability in the industry. It allows managers to identify the root cause of a batch of defective products. Therefore, prevent all products in a collection exposed to improper storage conditions from reaching patients.
Carefully tracing products is also an essential part of demand tracking to ensure the delivery of appropriate quantities of products. Supplying products by accurately predicting demand is integral to responsible warehousing and supply chain management.
Companies can maintain safe warehousing and supply chain practices that protect patients by carefully training staff, tracing products, and monitoring storage conditions.