The Major Challenges of Compliance in the Pharmaceutical Industry

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The Major Challenges of Compliance in the Pharmaceutical Industry

There are good reasons why pharmaceutical companies must contend with some of the most robust regulatory requirements of any sector of the economy.

Patients worldwide rely on pharmaceutical products for their continued health and longevity. Oversights and errors of pharmaceutical companies can have life-altering effects on patients and the healthcare system.

However, tightly regulating the pharmaceutical industry without stifling innovation is easier said than done.

Large pharmaceutical companies must spend substantial budgets on building compliance teams, rules, and procedures that ensure they’re complying with national and international regulations. Moreover, compliance teams must interact with several departments within pharmaceutical companies.

Coordinating compliance with different branches of the pharmaceutical industry, from manufacturers, supply chain, quality assurance, legal departments, and healthcare facilities and patients, is a significant challenge.

Diligent compliance teams must oversee each aspect of pharmaceutical drug development, cold data storage, transportation, and administration.

In addition, many people are unaware of how difficult or important it is for companies to keep up with changing or updated regulations. So let’s explore the significant compliance challenges in the pharmaceutical industry today.

Pharmaceutical Supply Chain Compliance Challenges

One of the trickiest parts of pharmaceutical compliance is carefully following regulatory guidelines when shipping pharmaceutical products.

That’s because many medical products must be stored at specific temperatures throughout each phase of their journey through the supply chain.

Supply chain procedures that carefully regulate the storage temperatures of products are cold chain storage in the industry.

Cold data storage is crucial for transporting many essential products, including food and medicines. However, lapses in cold chain storage procedures can harm consumers and patients.

As a result, regulators pay careful attention to the storage conditions of facilities storing medical products.

In particular, they require pharmaceutical companies to submit temperature readings of these facilities at regular intervals. Moreover, take these temperature readings using accurate, secure, and automated devices that ensure temperature data integrity.

To accomplish this, pharmaceutical companies use small electronic devices called data loggers that automatically measure and record storage temperatures at regular intervals.

Occasionally, store this data in the internal memory of each data logger before being transferred to third-party computer systems and data analysis software. Next, the data can be analyzed and formatted before being submitted to regulators.

In addition, utilize data loggers in conjunction with sophisticated cooling and refrigeration technologies to store medical products within safe temperature ranges throughout transit.

Cold Chain Storage for Vaccines

Cold data storage has become an area of increased interest for investors since it is necessary to transport COVID-19 vaccines to healthcare facilities and patients.

The Pfizer vaccine, for example, requires particularly low-temperature storage conditions to remain effective when stored for more extended periods. However, that represents a substantial compliance challenge for pharmaceutical companies.

More specifically, store the Pfizer COVID-19 vaccine at temperatures between -90 and -60 degrees Celsius.

This temperature range is well below what traditional freezer and refrigeration systems can provide. Therefore, Pfizer implemented its unique set of technologies to facilitate an effective cold chain storage solution for its vaccines.

Shipping containers that use dry ice to keep ambient temperatures at the ultra-low levels its vaccines require to distribute Pfizer vaccines.

In addition, Internet-connected data loggers equip shipping containers that send temperature data back to the manufacturer at regular time intervals.

The containers even include an interface that allows healthcare workers to verify the receipt of vaccines digitally and that the vaccines arrived undamaged and in good condition.

Temperature data from shipping containers and other storage facilities can be formatted and submitted to regulators.

This data also includes tracking, if storing vaccines at alternative temperatures and for how long. That’s important since the Pfizer vaccine can store at temperatures between 2 and 8 degrees Celsius for up to one month.

Another compliance challenge inherent in cold chain storage is the handling of temperature-sensitive medical products.

For example, in many cases, specialized instruments must be used when transporting products from one storage container to another to prevent body heat from impacting the temperature of the product.

Data Integrity Compliance and Cloud Computing

Some pharmaceutical companies’ most challenging compliance regulations are data integrity, security, and privacy.

However, this is true for storing temperature data and other types of data that pharmaceutical companies gather.

For example, when pharmaceutical companies conduct clinical trials to research new drugs, data collected from those trials must be carefully and securely stored and submitted to regulators or medical journals.

Failure to keep clinical trial data organized and secure can cast doubt on the findings of a trial and potentially jeopardize regulatory approval of pharmaceutical products.

Given that pharmaceutical companies spend many millions of dollars on clinical trials, the cost of not being able to bring a new product to market is exceptionally high.

Furthermore, collecting data that is biased or unscientific can lead to increased scrutiny of the trial and a loss of confidence in its findings. 

Many pharmaceutical companies are employing digital transformation strategies to meet challenges designed to ensure data integrity, security, and privacy.

Numerous pharmaceutical companies use cloud computing and cloud storage systems to store, centralize, format, and analyze pharmaceutical data.

Unlike data management solutions of the past which relied on companies buying, maintaining, and updating their own IT infrastructure, cloud computing allows firms to rent IT infrastructure and store data online.

The internet contains the data in the cloud, which means that data is far more shareable and accessible by permissioned third parties, partners, and regulators.

It also means that pharmaceutical companies can indirectly retain the technical talent from companies like Google, Amazon, and Microsoft to update IT systems and eliminate cybersecurity threats.

To sum up, we’ve seen how cold chain storage and data integrity are among the leading compliance challenges for pharmaceutical companies today.

As a result, companies are turning to modern data logging and cloud computing solutions to ensure regulatory compliance and keep patients safe.

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