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Biopharmaceutical waste amounts to $37 billion every year due to challenges within cold chain logistics.

(Source: Deloitte's 2022 Global Life Sciences Outlook Digitalization at Scale: Delivering on the Promise of Science Report.)

The biopharmaceutical and life sciences industry is now worth $1587.05 billion, as per the latest reports from the Business Research Company%20of%209.1%25.). To support the rapid expansion of this industry and ensure that high-value temperature-sensitive medicines and vaccines reach end-users at the correct time without being damaged, there is a need to completely digitise the supply chain and related operations using the latest IoT technologies.

The biopharma and life sciences industry face several challenges, which can impact the efficacy and safety of its products -

• Rapid temperature fluctuations can occur both in transit and in cold storage facilities & warehouses.
• Exposure to excessive light and heat can harm vaccines and other pharmaceutical products.
• Eventual shocks can break protective packaging cases of pharmaceutical products and can affect their viability.
• Supply chain visibility is limited in many places due to a lack of end-to-end visibility.
• With the massive set of information and data points involved, it can become difficult to develop key insights into everyday operations.
• Many stakeholders are involved in understanding challenges within pharmaceutical cold chain management, which can become a time-consuming and tedious task.
• Vaccine tracking is vital as many stakeholders are involved and the potential for excursions or fluctuations in temperature to occur.

Compliance Requirements In The Pharmaceutical Industry.

In order to overcome the obstacles that the pharmaceutical industry faces, which render its products unviable for usage, implementing innovative temperature data logger solutions can assist in the tracking and monitoring of temperature-sensitive products. This is in addition to also achieving greater operational efficiency and supply chain visibility throughout cold chain management processes.

With the use of these innovative IoT technologies, biopharma companies can achieve global compliance standards set by various organisations and countries. To give you an idea of what compliance standards exist -

The Australian Code Of Good Wholesaling Practice For Medicines: It establishes criteria that all third-party partners must follow. The guideline emphasises the need for monitoring during the transport of temperature-sensitive medications to ensure that the manufacturer-specified requirements are being met.

The Drug Supply Chain Security Act In 2015: The FDA in the United States of America passed a law requiring every medicinal product to be tracked from 2023 onwards.

FDA 21 CFR Part 11 Compliance

• Guide to cold chain compliance USA