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The pharmaceutical industry must operate with speed and precision. In recent years, the global pandemic shed light on the importance of acting with speed and agility when developing and delivering pharmaceutical products.
In the context of today’s complex and interconnected global pharmaceutical supply chains, which involves networks of partners dispersed across multiple locations, technology has assumed a pivotal role in streamlining operations.
The complexity of modern global supply chains means legacy, manual labelling solutions are no longer feasible. Though often overlooked, cloud-based labelling solutions, which automate previously labour-and cost- intensive operations, are becoming increasingly indispensable for manufacturers looking to streamline and enhance the efficiency of pharmaceutical labelling processes.
What’s more, the recent emergence of Artificial Intelligence (AI) is a new development that is worth noting as it holds the potential to deliver significant improvements to supply chain processes in the future.
This piece will explore the ways in which automation has transformed pharmaceutical labelling and packaging, highlighting its numerous benefits in enhancing accuracy and consistency, ensuring regulatory compliance, streamlining workflows, enhancing traceability, boosting product and patient safety, and expediting pharmaceutical products’ time-to-market.
Streamlining Workflows and Accelerating Time to Market
In the past, label and printing solutions used by pharmaceutical organisations were manual, disparate, and fragmented. There was no common or centralised data hub for handling the critical task of label template management. Manual processes were the norm, with labelling templates having to be generated in a labour-intensive process which not only compromised the speed of the product reaching the market but also introduced inconsistencies - hindering the ability to maintain consistent and compliant labelling practices.
Cloud-based labelling solutions, however, streamline workflows and accelerate time to market through simplifying and modernising the label creation process. This technology centralises data, making it easily accessible from a single location, eliminating the need to maintain and update multiple databases or systems, and thereby streamlining data management as result. This enhanced efficiency ensures that pharmaceutical products can move through the supply chain faster, meeting delivery expectations in an industry where timing is critical.
The real-time updates and remote access capabilities provided by cloud technology facilitate seamless collaboration and communication among teams and suppliers, further expediting the review and approval process. As a result, pharmaceutical companies are able to rapidly respond to market demands, accelerating the time to market while ensuring quality and accuracy.
Enhancing Accuracy and Consistency for Patient and Product Safety
Ensuring pharmaceutical labels are accurate is vital in an industry where patient safety is the top priority. According to a report from the Institute of Medicine, 30% of fatalities result from incorrect medication being given to patients on account of labelling errors. Rightly, the industry is responding with more stringent regulations – a raft of regulatory measures have been introduced to protect patients.
Furthermore, recent data indicates that approximately 50% of pharmaceutical recalls can be attributed to labelling or packaging artwork errors. As well as posing an immediate risk to patients, labelling inaccuracies can inflict substantial and lasting damage from a brand perspective. Being the subject of product recalls can severely tarnish a pharmaceutical company’s reputation and can also negatively affect the likelihood of future approvals. The financial costs of recalls, especially for widely-distributed products, can be staggering, with regulatory bodies imposing hefty fines.
Given the health-related, reputational, and financial risks, pharmaceutical manufacturers are proactively mitigating against product recalls. To do so, they need to have a robust and reliable labelling function. Cloud-based labelling solutions, with their automated label verification capabilities, offer a powerful means to protect public safety while also ensuring product quality, regulatory compliance, and operational efficiency.
The automation capabilities of cloud-based technologies play a pivotal role in enhancing speed and accuracy of pharmaceutical labelling. These platforms can automatically cross-check labels against predefined standards, flagging labels that do not meet these specifications for review or rejection. This minimises the risk of human oversight and errors during the inspection process.
Moreover, cloud-labelling systems excel in speed, as they can rapidly detect discrepancies and errors, far outpacing human capabilities. Their ability to analyse large datasets and inspect labels at a swift pace ensures quicker error detection and correction. The speed and precision offered by such a technology is essential in preventing labelling issues from reaching the market, thereby safeguarding both patient safety and the pharmaceutical industry's integrity.
Adhering to Important Regulations
The fact that there are varying standards and regulations across different markets and jurisdictions makes compliance a challenge for internationally traded goods.
Manufacturers need label databases that can host numerous label variants, which can be updated in a timely and cost-effective manner. Even when digitised, the creation of multiple label templates can be laborious and processing label changes can be a significant challenge. This is a particular burden for pharmaceutical manufacturers as regulations such as FD and CFR 21 require every change to be documented within the system, including new and updated label templates.
The Cloud digitises the entire labelling management process, from design and printing to management. The centralised, digital label catalogue eliminates the need for cumbersome paper-based catalogues, preventing the data silos and thus efficiently controlling and streamlining label management.
Cloud also paves the way to compliance - features such as role-based access, electronic signatures, and configurable approach workflows help to ensure the necessary documentation is in place to meet stringent regulatory requirements.
Furthermore, the incorporation of label variant technology helps to reduce the multitude of label templates that pharmaceutical companies are required to maintain. Through one centralised labelling system, pharmaceutical companies are able to ensure label accuracy and consistency required for compliance and ensure patient safety.
Improving Traceability
Pharmaceutical manufacturers operate within a highly regulated environment. Compliance with stringent labelling requirements is crucial to avoid costly disruptions.
Research shows labelling or packaging artwork errors contribute to around half of all product recalls, with an average recall notice costing $8 million. Additionally, according to Gartner, compliance violations in the pharmaceutical industry have exceeded $50 billion since 2000, while the average cost of non-compliance has grown by 43% over the past nine years. The sector must therefore prioritise the careful management of global supply chain products, ensuring accuracy at every stage to guarantee full traceability and the highest level of safety for every pharmaceutical product on the market. A single error can prove fatal, making it crucial for pharmaceutical companies to have complete visibility and the capability to track their products.
Serialization plays a pivotal role here, offering a distinct serial number to every product unit, including crucial details such as origin, batch number and validity date. By printing this code on packaging, organisations can seamlessly track and trace products throughout the supply chain. Cloud technology is integral to this process, as it enables the storage, sharing, and real-time access to important data, providing pharmaceutical companies with the ability to track and trace products throughout the supply chain.
Looking Ahead
When discussing the influence of technological advancements in enhancing pharmaceutical manufacturing, it is essential to acknowledge the pivotal role of AI and automation.
Within the pharmaceutical industry, AI is currently employed in drug development to scrutinise vast datasets and pinpoint potential drug targets. However, looking ahead, the transformative potential of AI and automation could extend into drug manufacturing and packaging.
We expect it to play a more significant role in automating complex tasks, such as the real-time monitoring of labelled products, managing inventory, and enhancing overall operational efficiency. As increasingly sophisticated algorithms emerge, these advancements promise to deliver numerous benefits, ultimately fostering accelerated production and heightened agility within the pharmaceutical manufacturing sector.