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Manufacture Quality & Compliance, Process Control, Technology and Equipment, Digital Technologies, Vaccines

Always Watching

When it comes to medicines and vaccines, getting storage right is crucial. Although it is common knowledge that the chemical properties of active ingredients in medicines and vaccines can change in different conditions, especially temperature and humidity, I find too often that organizations fail to effectively and reliably monitor product quality on an ongoing basis, especially within the distribution chain.

Monitoring is not a new concept. In the pharmaceutical and drug manufacturing space, product quality monitoring has been a requirement for more than 50 years. Established pharmaceutical manufacturers know this and take the necessary steps to ensure that they can effectively observe the medicines and vaccines they produce. However, there are challenges as they work to ensure that every organization that plays a part in pharmaceutical distribution continuously monitors product quality to guarantee the safe, effective, and compliant production, transportation, and storage of medicines and vaccines.

In the US, there has been a concerted effort toward this end.  The shift in attitude across the country began almost two decades ago as focus was placed on security and domestic protections against bioterrorism. The Strategic National Stockpile was created with initial funding of over $600 billion, and included products such as vaccines and antibiotics.  This effort, managed partially by the FDA, brought attention to challenges of strengthening supply chains and ensuring proper long term storage of temperature sensitive drug products. Soon after, significant focus went into creating Good Distribution Practices for pharmaceutical products (1). The goal of the framework is to ensure that every organization along the distribution chain understands and can implement the right technologies to adhere to specific monitoring requirements.

Monitoring systems have advanced significantly over the years. Today, there is increasing focus on continuous monitoring systems that allow companies to remotely check temperature, relative humidity, differential pressure, door switches, and other important parameters. Factors from the size of the facility to the different types of medications produced and stored there affect the time required to monitor pharmaceutical products – but, by positioning data loggers in every area where specific parameters must be monitored, the time-consuming manual workload is essentially eliminated.

Continuous monitoring technology can also scale easily – from one or two measurement points to thousands of monitored areas – and advances in technology ensure gap-free monitoring even during power and network outages. Organizations can identify whether the temperature, humidity, and other parameters fluctuate too much in a specific location and take action to ensure product safety in the short term and mitigate the issue in the long term. By using historical data, lab technicians can also generate trend-line graphs that indicate a slow temperature increase in refrigerators or freezers or even possibly predict problems such as compressor failures.

But the story is not over; monitoring technology is always evolving. I believe that monitoring will continue moving to the cloud and that novel technologies – perhaps blockchain or something the industry has not even considered – will eventually become the new way to monitor.

In the end, pharmaceutical innovation is not always flashy. Organizations across the pharma distribution chain need continuous monitoring solutions that are reliable, worth the investment, and won’t need to be replaced as organizations grow and research evolves. But patients just want medicines and vaccines that prevent, treat, and protect them from harmful – sometimes deadly – diseases. We must do our best to respond to that need.

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  1. WHO, “WHO good distribution practices for pharmaceutical products” (2010). Available at https://bit.ly/3DgjFmp.
About the Author
Paul Daniel

Senior GxP Regulatory Expert at Vaisala, Inc. in Woburn, MA

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