Storage conditions are critical to ensuring that pharmaceutical products remain safe and effective. Without proper precautions and storage procedures, delicate pharmaceuticals and biologics are at greater risk of being exposed to incorrect temperatures and humidities.
Improper warehouse storage conditions for pharmaceutical products can lead to costly product wastage. It can also damage a company’s reputation and brand equity or, even worse, put patients at risk with potentially ineffective medical products.
What is Pharmaceutical Product Quality?
Pharmaceutical products are increasingly sensitive and prone to becoming unusable when not meeting their special storage needs. Therefore, these medical products must be transported, stored, manufactured, and distributed in a manner that meets the specific needs of each product. In addition, the manufacturers design these particular product requirements to ensure that the products stay in a state of usable quality for as long as possible.
Several factors define the quality of a product. Product quality attributes include correct identification, operation safety, efficacy, and purity. In addition, maintaining the proper storage conditions is critical in supporting all aspects of product quality.
Warehouse storage conditions must maintain products and limit the risk to patients. These patients have a moral and legal right to expect the manufacturer’s claim of quality pharmaceuticals. If any product is damaged or degraded at any point in storage, creation, or transport, it must be disposed of, which can be very costly for pharmaceutical companies.
Warehouse Storage Responsibility:
When a warehouse receives a pharmaceutical product, the individual product does not undergo further inspections or quality control tests. Therefore, the warehouse is responsible for maintaining optimal storage conditions to prevent product degradation.
Thanks to these risks, it’s vital that warehouse storage conditions use standardized procedures with a well-trained staff to ensure products are stored, handled, and delivered as safely as possible with all quality intact.
Explaining GWP and GDP
According to Dickson Data, warehouse storage conditions have established several rules and regulations as an industry standard. These rules are in place to protect products from poor storage quality or incorrect distribution practices, classified as GWP or GDP.
GWP stands for Good Warehousing Practice. These are precisely the practices that involve warehouse storage conditions and procedures. It includes maintaining quality control standards of warehouse storage environments and equipment.
GDP stands for Good Distribution Practice, the distribution and general transport of products. GDP can involve the shipping of products, distribution regulations, and the fulfillment of pick-up requests.
Many of the practices pertain to one apply to both and ensure a high degree of control on receiving pharmaceutical goods.
Best Storage Practices
Improper storage and loss of product from incorrect warehouse storage conditions are among the most expensive mistakes that pharmaceutical companies can make. Therefore, exceptionally costly for drugs that are often in low supply, where every shipment can make a difference.
Preventing costly treatments from being damaged is paramount to ensuring medication is smoothly distributed and applied safely, but it doesn’t always work out.
Improper handling causes an estimated 15% of temperature-sensitive pharmaceutical waste. Therefore, up to a loss of nearly $35 billion a year, and that accounts for temperature-related issues.
Adhere to warehouse storage conditions by following several standard rules to minimize the deterioration and contamination of products, especially for sensitive products needing specialized requirements to remain usable.
Examples include some COVID-19 vaccines, which require extremely low temperatures to remain usable. If these conditions are unmet, the vaccines, which continue to be authorized, will deteriorate and become unusable.
Below are some examples of standard warehouse storage conditions requirements:
In GWP warehouses, it’s common to ensure that packs should never be left unsealed, preventing possible contaminants in the environment, such as dirt or insects, from impacting products.
Therefore, store all products within their specified temperatures. These instructions can be as simple as “do not freeze” or provide an exact temperature range between 2 to 8 degrees Celsius.
Warehouses should use a FIFO (First In, First Out) system. Many pharmaceuticals deteriorate with time or even have expiration dates. Therefore, properly rotate stock to prevent old products from being stored passed their expiration date.
Warehouse exits and doors should remain closed whenever possible to limit exposure to unstable conditions further and keep temperature controls in check. In addition, warehouses must be kept orderly, clean, and dry at all times.
Along with all these rules, following them closely and consistently monitoring temperatures is imperative. Therefore, monitor freezers, refrigerators, and regular warehouse temperatures. In addition, investigate all temperature deviations. Finally, assess the impact and determine which products are no longer viable when a divergence occurs in temperature that puts pharmaceutical products at risk.
How Sensitive Material is Monitored
Keeping track of warehouse storage conditions requires a lot of specialized equipment and near-constant monitoring. It’s a task that no single human can do without the help of special tools like data loggers.
With the extra help of data loggers, which electronically measure and record temperature conditions, more exact readings can be kept in warehouse storage. In addition, a data logger helps with logistics, pinpointing where and when errors occur and eliminating much of the risk of human error.
In the long term, this also helps to improve warehouse storage procedures. But, most importantly, it helps to identify a compromised product and ensure that patients do not receive any pharmaceutical product beyond the point of safe usability.
With this little extra bit of digital help, it becomes possible to keep track of everything that is going on in a warehouse. In addition, with a well-trained team using these tools, the risk of further costs from damaged products becomes substantially mitigated.