Healthcare facilities, hospitals, and pharmacies worldwide depend on the pharmaceutical supply chain to keep their shelves stocked and continue offering the medications and pharmaceutical products patients rely on. Unfortunately, many people are unaware of the many moving parts that create secure supply chains that get pharmaceutical products to patients without compromising pharmaceutical quality assurance standards.
Supply chain management mistakes, or even minor lapses in judgment, can put patients’ health in danger by making the medicines they rely on unavailable, ineffective, or unsafe. As a result, regulators in charge of ensuring the reliability of global pharmaceutical supply chains and quality assurance take their jobs seriously. As a result, even minor regulatory infractions by pharmaceutical companies can lead to steep fines, civil litigation, and even criminal penalties.
Regulatory compliance is critical when establishing supply chains that keep pharmaceutical products at required temperatures to prevent them from becoming ineffective. Creating temperature-controlled supply chains, known as cold chain storage systems, are among the most significant challenges of pharmaceutical companies today. Accordingly, let’s establish a quick guide that pharmaceutical professionals should keep when considering cold storage for pharmaceuticals.
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Use Data Loggers to Monitor the Temperature of Pharmaceutical Storage Facilities
An essential part of cold storage for pharmaceuticals is carefully monitoring storage facilities’ temperatures at regular intervals by manually using analog temperature measuring devices like thermometers.
Luckily, today companies have an array of modern digital options such as data loggers and ambient temperature monitors at their disposal to meet this challenge. Data loggers are small electronic devices that record environmental data. For example, depending on the model of the data logger, they can record temperature, humidity, and differential pressure data.
Importantly, data loggers can measure and record temperature data completely automatedly, representing how big data changes our work and life. Automation decreases labor costs and reduces the possibility of human error for pharmaceutical companies. Store temperature data on the devices’ internal memory and later transfer it to external computers or IT infrastructure.
Pharmaceutical companies must be careful to format collected data before submitting it to regulators correctly. In addition, compliance professionals should use the correct data loggers and formatting techniques to streamline regulatory approval.
Implement a Temperature Mapping Strategy
One of the most common mistakes pharmaceutical companies make when using data loggers to monitor storage conditions is neglecting to implement a temperature mapping strategy. Regarding cold storage for pharmaceuticals, Dickson&Data says that temperature mapping is often necessary because temperatures can vary in different areas within the same storage unit. Therefore, affixing a data logger to one side of a storage facility might present an inaccurate picture of the temperature within the facility at large.
Several factors can cause this differentiation of temperatures within a storage unit that pharmaceutical companies should be aware of. These include the ventilation of airflow around the unit, the unit’s cooling mechanism, the unit’s load, and the unit’s physical placement in a facility. In addition, in many cases, managers should also be aware of other storage conditions that could affect products, such as the humidity, moisture, and pressurization of a unit.
To take temperature differences within storage units into account, supply chain managers affix multiple data loggers to different areas within the same storage unit. As a result, this gives them data points of temperatures in each unit area, which can then be tracked, analyzed, and mapped. Supply chain managers can even consider using data loggers that send automatic alerts if any area of a storage unit deviates from acceptable temperatures.
Explore Data Storage and Cloud Computing Options
After implementing effective data gathering and temperature mapping techniques, pharmaceutical companies typically explore how best to store, organize, and format this data before submitting it to regulators. Traditionally, pharmaceutical companies maintained their hard drives and IT infrastructure to store temperature data. However, maintaining and updating these systems can represent a high cost for pharmaceutical companies.
Today, some companies are exploring alternative approaches to collecting storage and customer data, such as working with third-party cloud storage providers to store and manage data in the cloud. Cloud storage providers such as Amazon Web Services, Google Cloud Platform, and Microsoft Cloud present some undeniable benefits for the pharmaceutical industry.
First and foremost, it prevents companies from maintaining as much of their IT infrastructure and talent, which can cut down on automated database testing and storage costs. Storing data on the cloud also makes it more easily shareable since multiple devices with permission can access it over the internet. Finally, since cloud service providers perform their security updates, storing data in the cloud can represent a cybersecurity benefit for many companies.
Ensure that Pharmaceutical Products are Handled Correctly
Pharmaceutical companies must take deliberate steps to ensure proper product handling. Therefore, it is especially true for temperature-sensitive products since handling them without the appropriate instruments and equipment can increase their temperatures. In addition, companies should provide clear instructions for their products to healthcare facilities, doctors, and supply chain workers that handle them.
In addition, include several vital points in these instructions—the effects of how air, moisture, and light on products should be made clear. The correct storage conditions and guidelines should indicate the necessity of not storing products next to heat-producing appliances or equipment.
Product transplantation restrictions related to new containers or pill bottles should be specified. In addition, how to tell when medicine has become damaged, such as when pills stick together, should be explained. Finally, companies should detail how to dispose of damaged or unusable products properly.
To wrap up, implementing a cold chain storage strategy is multifaceted and includes many necessary steps. Leveraging the power of data loggers, cloud computing, and careful handling instructions is an excellent place to start for pharmaceutical companies that care about assuring the quality of their products. The pharmaceutical industry can make cold storage for pharmaceuticals more resilient and helpful to patients by ensuring their safety and making the company less vulnerable to regulatory infringement.