It’s a transformational time for drug development, with radical new therapies and a wider variety of delivery methods coming to the market every day. However, ongoing drug shortages are affecting patients worldwide. Why is this happening, and what can companies do to stabilize drug production?
Pharma stakeholders invest heavily in developing breakthrough drugs and divert experienced staff to new manufacturing lines, often at the expense of meeting production goals for existing drugs. This lack of focus on ‘less exciting’ products can lead to GMP deviations and insufficient quantities of important therapies, including generics.
To address drug shortages, we need career paths in manufacturing that attract talent and promote retention and skill growth. Diverting top talent to drug development or new plant construction leaves current operations understaffed.
Talent shortages leave manufacturing sites without experienced leaders and operators, straining the workforce as non-compliance with FDA standards must be addressed before products can be released. The industry must grow the workforce and streamline operations to tackle this issue.
Building the right culture
Fundamental to successful operations is a workforce capable of manufacturing drugs in a controlled, non-variable manner. They must be trained to have exceptional attention to detail, be able to follow procedures meticulously and understand the processes they’re following well enough to recognize and act on problems.
To facilitate this, pharma must foster a culture of seeking continued education. Junior employees should feel confident, knowing they’ll receive the hands-on training necessary to advance in the workforce. It is essential to build a positive culture where employees feel comfortable speaking up when they don’t understand something. It fosters a hunger in workers to constantly improve, which enhances a manufacturing plant’s output in the long run.
Role clarity in a manufacturing plant means that every project step that requires specific skills and knowledge is assigned to a trained and qualified worker. All workers know who has been assigned each task, and therefore, every worker should understand their role and how it fits into the entire drug manufacturing process. However, a lack of role clarity is a common problem in plants.
Without role clarity, workers may take on too many responsibilities or may be unsure which tasks are most relevant for their roles. Either way, this leads to operational inefficiencies destabilizing manufacturing and supply. A culture of personal responsibility ensures minimal deviations in the manufacturing process that might prevent a drug product from reaching patients.
Breaking down silos
You don’t solve operational problems in a conference room. Minimizing silos between the C-suite and facility operations is critical to preventing manufacturing bottlenecks. The C-suite naturally focuses on new development projects, but plant operations benefit when senior leaders engage with workers on the floor, addressing issues early to prevent delays. If leaders stay removed, teams may feel marginalized, workers may be shifted to development, and deviations can backlog, awaiting investigation. Remember, feedback is a gift: it teaches us how to improve. In pharma, deviations are feedback about processes, but they’ve always been analyzed manually. Younger workers bring training in AI and advanced data systems, enabling the industry to gain deeper insight into why deviations occur and how to address them effectively.
Improving overall operations
Companies can mitigate drug shortages by dedicating enough resources to plants, people, and processes to consistently manufacture high-quality drugs. This requires prioritizing skill advancement, clarifying roles, and tracking inefficiencies to address them effectively.
Addressing shortages increases access to critical medications, helping patients receive the treatments they rely on to improve their quality of life.