The proper storage and distribution of medical products is essential for pharmaceutical companies to protect patients and comply with local and federal regulations. Improper storage of medications or vaccines can result in medical products that are degraded or contaminated. It can also leave pharmaceutical companies vulnerable to lawsuits and legal liability.
Pharma storage best practices must be implemented not just in healthcare facilities, but also throughout the entire pharma supply chain. Pharmaceutical products must be properly stored at each step of their journey, to retailers and patients, to abide by Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) standards.
Realizing that storage is vital for pharmaceutical products, many companies have dedicated compliance and quality assurance divisions that are tasked with standardizing storage practices. Companies must also oversee the shipping and handling of these products to ensure quality and regulatory compliance.
Many people still aren’t aware of the procedures that companies must follow to comply with state and federal guidelines, so let’s explore the pharma storage compliance best practices that these companies should follow.
Quality Management Systems
Good Manufacturing Practices (GMP) are standards set forth by the Food and Drug Administration (FDA) that supervise the production of pharmaceutical products. These standards are meant to prevent harmful contaminants from making their way into medical products. To this end, there are regulations that require certain pharmaceutical products not be made using the same equipment that manufactures compounds that are toxic to humans.
To comply with GMP standards, pharmaceutical companies use quality management systems that collect and analyze data about the manufacturing process. A quality management system is a software solution that is approved by the FDA for collecting and authenticating electronic records of manufacturing practices. This allows pharmaceutical companies to organize, store, and submit compliance documents without keeping paper records.
These quality management systems can be used to transfer information across divisions and industries, as well as to regulators, and are an integral part of pharma compliance.
Cold Chain Management
Pharma storage compliance gets even more complicated when transporting medical products that are temperature-sensitive. Many medicines can degrade or become unstable when exposed to temperatures that are too high. This has created a need for temperature-controlled supply chains, known in the industry as cold chain storage.
As you might imagine, companies that ship or sell these products must abide by regulations that supervise the safety of cold chain storage to protect patients. Doing so is more difficult than you might think since even slight deviations in the temperature of storage facilities can affect pharmaceutical products.
To safeguard the integrity of the cold chain, pharmaceutical companies must make use of powerful technological solutions.
Data Monitoring and Data Loggers
Environmental data monitoring and pharma compliance systems are crucial to maintaining the integrity of the cold chain and the pharmaceutical manufacturing process. Data loggers are small electronic devices that collect environmental data such as temperature, humidity, and differential pressure. According to Dickson, this data is stored in the device’s internal storage and can later be transported to an external hard drive or computer.
Pharmaceutical companies can then format this data using powerful software systems so that it can be submitted to regulatory agencies. This is important because regulators actually require pharmaceutical companies to record and submit this data as part of their compliance programs.
Often, the temperatures within a storage facility can vary. This is why cold chain storage managers must often use several data loggers in different areas within the same storage container. Temperature data gathered using this approach can be managed and incorporated into a temperature map using sophisticated software solutions.
Certain data loggers can be connected to the internet and transmit data to pharmaceutical companies online. This offers a few advantages. Namely, the temperature of storage facilities can be monitored in real time, and many of these data loggers can even be configured to send automated alerts if temperatures deviate outside of expected ranges.
In the case of internet-enabled data loggers, steps should be taken to ensure that temperature data is being transmitted over a secure network to make sure that the data remains confidential. Introducing an up-to-date cybersecurity strategy is an important best practice to maintain storage compliance.
Maintaining Storage Facilities and Handling Products
Pharmaceutical companies must carefully consider the environment that their storage facilities are in and the potential surrounding hazards that might damage products. Ventilation systems are becoming an even higher priority thanks to the COVID-19 pandemic.
For example, ventilation systems must be established to prevent storage facilities or freezers from overheating or malfunctioning. Industrial fans that carefully direct airflow are very helpful to make sure freezer equipment functions properly.
Preventing microbial growth is also a critical best practice in pharma compliance. It’s best not to allow liquids or drinks near storage facilities since spills are a common cause of microbial contamination. If a spill does occur, it must be deeply cleaned, disinfected, and dried immediately.
Condensation can also impact storage facilities that use both warm and cool components. While airflow and ventilation can often prevent this, it’s still important for supply chain managers to monitor condensation and adjust the position of storage facilities if necessary. These environmental concerns are becoming increasingly pertinent today due to supply chain concerns.
Storage containers must be carefully mobilized and often stored for specific amounts of time at receiving bay areas. This will help ensure that medical products don’t spend too much time outside of optimal storage conditions throughout transport.
Healthcare workers must also be trained on how to handle products in a way that does not compromise pharma compliance standards. Many temperature-sensitive medical products, for example, should not be handled with bare hands since body heat could increase their temperature. In these cases, healthcare workers must use temperature-controlled instruments to handle products when moving them from one storage container to another.
To sum up, pharmaceutical companies should take steps to introduce a quality management system, data loggers, shipping and handling protocols, and reduce environmental hazards like poor ventilation and condensation. These are just a few of the most important best practices to make sure pharma storage policies comply with regulatory guidelines.