Poor storage conditions that expose delicate pharmaceuticals and biologics to changes in temperature and humidity can be very costly in the form of lost product, poor end quality for patients, and damage to reputation.

What Defines Pharmaceutical Product Quality?

Pharmaceutical products must be manufactured, transported, stored, and distributed in a specific manner that meets the specific product requirements designated by the manufacturer. Quality of products is defined by purity, correct identification, efficacy, and safety of use. The correct storage conditions are critical to maintaining quality. Customers and patients have a right, legally and ethically, to expect quality pharmaceuticals that do what they claim to do. When storage conditions are poor, with variances in temperature and humidity – the quality of the product can be compromised, resulting in it being less effective, or even creating volatile compounds. 

Once a pharmaceutical product is received in a warehouse, no further inspections or quality control tests are conducted on the individual product. It is the warehouse’s responsibility to maintain optimum conditions to preserve the product quality. If the product is degraded or damaged at this juncture, there is no safeguard to prevent it from being given to the patient. Because of this risk, it is crucial that the warehouse use standard procedures and well-trained staff to ensure that products are handled, stored, and delivered safely and with the same quality intact. 

What is GWP and GDP?

To protect product from poor storage and distribution practices, rules and regulations have been established to manage the industry. Good Warehousing Practice, or GWP, refers specifically to the practices in the company warehouse. Good Distribution Practice, or GDP, refers specifically to the transport and distribution of product. Some of the practices that are dictated by GWP and GDP include controls over the way goods are received, quality control of the warehouse storage environment, managing components and products, fulfilling picking requests, and shipping the product to its destination. 

Specific industry rules under GWP and GDP allow manufacturers to:

• Protect pharmaceuticals from damage during transport
• Prevent degradation of the product by exposure to adverse environmental/temperature conditions
• Avoid contamination by other materials
• Maintain product identification and traceability
• Prevent time-expired and damaged material or product from being used
  
  

Best Practices for Storage

One of the costliest issues that can happen in the pharmaceutical industry is improper storage and loss of product. In fact, a 2019 IQVIA Institute study found that around 15% of temperature-sensitive pharmaceuticals were wasted, adding up to a loss of around $35 billion annually. These numbers are for temperature-related issues alone. Furthermore, another study performed revealed that 25% of vaccines may have degraded efficacy due to failure to maintain the cold chain. This means that storage conditions for pharmaceuticals are of priority importance for pharmaceutical companies that need to protect their product and move it through the distribution chain to pharmacies without incident. 

To prevent contamination and deterioration of product during warehousing, the following common warehouse rules must be followed:

• No packs should be left unsealed. This practice prevents possible contamination from dirt, the environment, or insects. 
• All pharmaceutical products must be stored within their labeled temperature zones. Some examples are:
  • Store at 2°C - 8°C
  • Do not freeze
  • Store below 25°C
• Warehouses should also use a first-in, first-out (FIFO) system. Since pharmaceuticals can also deteriorate over time and lose efficacy, they have specific expiration dates. If stock is not rotated properly, this practice could result in partly degraded or old product being used – negatively impacting patient outcomes
• Warehouses must also remain aware of the chemical handling hazards of certain products in the pharmaceutical industry. Chemical spillage procedures must be followed to ensure that personnel and other products are protected. Incidents should always be reported
• To maintain the steady environmental conditions required, warehouse outer doors and exits should be closed whenever possible. Exposure to the elements can result in hot or cold temperature excursions and outside dirt and pest contamination
• Product must always be labeled and labeled correctly. If it is not, or the label is missing, the stock should not be used
• The warehouse must also be kept clean, dry, and orderly at all times. This means:
  • Protecting receiving areas from inclement weather
  • Regular checks that ensure storage containers and packs are sealed properly
  • A regular cleaning schedule that is maintained
  • Cleaning all spills immediately

• Temperature monitoring is a very important component of warehousing pharmaceuticals 
  • All freezers and refrigerators should be monitored and alarmed. 
  • Regular warehouse temperatures in other areas should also be monitored, especially with goods that have a required storage temperature to maintain. 
  • All temperature records should be reviewed and analyzed frequently.
  • All temperature deviations should be investigated, and the impact assessed. 

What is a Pharma Freezer Farm?

Another specific type of storage facility for pharmaceuticals is widely known as a “freezer farm”. These facilities can provide ultracold storage at -80°C, and cold at -20°F. Specific vaccines and medications must be held at these temperatures and only thawed right before use. For example, during the COVID-19 epidemic, one ultracold storage facility at the University of Arizona was utilized to store more than 1.6 million doses of COVID-19 vaccine. Freezer farms are also used to bank biological specimens for research purposes and storage.

Freezer farms are highly managed to prevent technical issues and power outages. Typically tanks of liquid nitrogen are kept on hand in case of an incident so that product can be maintained. 24/7 temperature monitoring is crucial to prevent excursions and maintain efficiency. 

Dickson environmental monitoring solutions have been helping warehouses stay compliant for many years. Our experience in the industry makes us a valued partner for providing data loggers and cloud-based software solutions that keep pharmaceuticals safe all over the world. For more information, please contact us at: 630-543-3747.