Placing Regulatory Compliance at the Core of Pharmaceutical Supply Chains
Optimising Efficiency with Data Loggers
In the fast-paced and highly regulated landscape of the pharmaceutical industry, ensuring compliance with stringent regulatory standards is not just a legal requirement but a fundamental aspect of maintaining public trust and safety. The integration of advanced technologies, such as data loggers, into pharmaceutical supply chains has become a crucial strategy for companies to navigate the complex web of regulations while concurrently enhancing operational efficiency.
The AiroSensor wireless data loggers, manufactured by the market-leading temperature surveillance solutions company SenseAnywhere, have emerged as a powerful and reliable tool for pharmaceutical companies seeking to enhance regulatory compliance and streamline their supply chain operations.
Navigating Regulatory Complexity
The pharmaceutical sector operates within a maze of regulations, including Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and various regional and international standards. A key example is that under GDP legislation the environmental conditions of the distribution process must be controlled. Moreover, equipment used for monitoring environmental conditions has to be calibrated at a specified interval and with proven competence. Failure to comply with these regulations not only poses legal consequences for pharmaceutical companies but can jeopardize the quality and efficacy of medications, ultimately impacting patient well-being.
This is why SenseAnywhere’s temperature surveillance solutions are designed to be fully compliant with pharmaceutical industry regulations. The AiroSensor data loggers comply with the strictest EU regulations for data loggers EN12830:2018 accuracy class 0.2. The measuring equipment is also calibrated to provide ultra-secure and reliable monitoring of temperature-sensitive pharmaceuticals at SenseAnywhere’s own Calibration Laboratory which is ISO 17025 accredited. In addition, the SenseAnywhere conforms with the GAMP 5 requirements and the AiroSensor software is compliant with the FDA 21 CFR part 11 regulatory requirements, making it the ideal fully compliant solution for the pharma industry supply chain.
The Key Role of Data Loggers in Compliance
The AiroSensor Data loggers are sophisticated devices designed to monitor and record temperature and humidity conditions. They can play a pivotal role in ensuring compliance throughout the pharmaceutical supply chain. These devices offer real-time tracking and 24/7 real-time audit and reporting functionality.
With an unwavering commitment to data security, SenseAnywhere is amongst the first in the market to be certified under the latest ISO 27001:2022 standard for Information Security. This accomplishment serves as a testament to SenseAnywhere’s dedication to safeguarding its clients’ data through the implementation of the most up-to-date security practices, providing them with peace of mind and complete confidence in their data protection compliance.
SenseAnywhere’s AiroSensor data loggers leverage secure cloud-based data storage, enhancing data management and accessibility. These features allow stakeholders to monitor conditions at various points in the supply chain. The cloud-based storage ensures complete data integrity and provides a centralized repository for compliance documentation.
Monitoring of Temperature-sensitive Pharmaceuticals
A substantial portion of pharmaceuticals is temperature-sensitive, requiring strict temperature control throughout the supply chain. Data loggers equipped with sensors provide continuous monitoring, alerting stakeholders to any deviations from specified temperature ranges. This capability is particularly crucial for preserving the integrity of vaccines, biological therapeutics, and other temperature-sensitive medications. This became pertinently important during the COVID-19 pandemic, as most vaccines required ultra-low temperature (ULT) storage and transportation conditions.
The AiroSensor Model 20-20-24/25 data logger provides an accurate temperature monitoring range of -30°C to 70°C. In addition, SenseAnywhere has developed advanced ULT products like the class-A wire-wound ceramic Pt100 Probe enabling accurate measurements across the entire temperature range of -200°C to +200°C.
Ensuring Product Integrity
Real-time monitoring allows for immediate response to deviations from specified environmental conditions, reducing the risk of compromised product quality and regulatory non-compliance. Therefore, the deployment of data loggers goes beyond compliance, it serves as a proactive measure to ensure product integrity. By constantly monitoring and recording environmental conditions, pharmaceutical companies can identify potential issues before they compromise the quality of the products. This proactive approach not only safeguards patient safety but also minimizes the risk of financial losses due to product recalls.
SenseAnywhere has launched the groundbreaking Temp Only and Temp/RH Modules enabling the most precise and rapid measurement of relative humidity and/or temperature, respectively. Both modules have a short response time, which makes them excellent for use in dynamic environments.
Streamlining Supply Chain Efficiency
Beyond legislative compliance, the integration of data loggers contributes to the optimisation of pharmaceutical supply chain operations. Real-time data allows for improved visibility, enabling swift decision-making in response to unforeseen events. This heightened agility reduces the likelihood of supply chain disruptions, ensuring a steady flow of medications to healthcare providers and ultimately to patients.
To further fortify compliance efforts, AiroSensor data loggers offer real-time notifications and alerts, with versatile notification options, including email, SMS, or voice calls, tailored to meet the specific preferences of its clients. This feature ensures timely and effective communication in the most convenient and flexible manner.
Stakeholders receive instant alerts in the event of temperature excursions or other critical deviations, enabling proactive risk mitigation. This feature empowers pharmaceutical companies to address issues promptly, preventing potential product losses and ensuring continuous supply chain efficiency.
Regulatory Compliance as a Competitive Advantage
Embracing data logger technology not only satisfies regulatory requirements but can also serve as a competitive advantage. Companies that demonstrate a commitment to maintaining the highest standards of product quality and regulatory compliance are more likely to foster trust among healthcare providers, regulatory bodies, and consumers.
Moreover, sustainability is also an increasingly important competitive advantage for companies. SenseAnywhere is committed to reducing the environmental impact in the production of temperature monitoring devices and is ISO 14001 certified, an integral part of the European Union’s Eco-Management and Audit Scheme (EMAS). The company’s data loggers are engineered with sustainability at the forefront. The AiroSensor data loggers have a battery life of 10 years, contributing to a huge reduction of chemical waste from replaced batteries. By adopting these sustainable products and practices, pharma companies can reduce their environmental impact, lower their operating costs, and enhance their reputation.
The Future of Compliance in Pharma Supply Chains
As regulatory standards continue to evolve, the pharmaceutical industry must stay ahead of the curve by embracing innovative technologies. The integration of data loggers is just one example of how the industry can proactively address compliance challenges while simultaneously enhancing operational efficiency.
Placing regulatory compliance at the core of pharmaceutical supply chains is not merely a legal obligation but a strategic imperative. By leveraging the capabilities of data loggers, pharmaceutical companies can navigate the regulatory landscape with confidence, ensuring the consistent delivery of safe and effective medications to patients worldwide.
The AiroSensor wireless data loggers by SenseAnywhere represent a pivotal advancement in ensuring regulatory compliance and optimizing efficiency within pharmaceutical supply chains. With features such as wireless technology, extended battery life, accurate temperature monitoring, secure cloud-based storage, and real-time audit capabilities, AiroSensor data loggers empower pharmaceutical companies to not only meet regulatory standards but also gain a competitive edge in delivering safe and effective medications to patients worldwide.
