Large engineering companies specializing in the industrial production sector have increasingly been adding process architects to their teams to address the need for expert designers in this specialized field.
Drug stability data that deviate from an expected trend when compared to other stability batches or historical data collected during stability studies are considered out-of-trend (OOT) results. According to the US Food and Drug Administration’s “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry,” OOT results should be limited and...
The production of advanced therapy medicinal products (ATMPs) can have many complex manual steps, which necessitates meticulous aseptic processing conditions to ensure the product is sterile, which is critical for patient safety. Closed isolator systems provide a consistent, compliant, and cost-effective solution, and can play a critical role in ensuring the safety of ATMPs.
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No organization survives for a long period of time if it does not change with the times. The pace of change is accelerating, and the scale of disruptive market forces is growing by the day.
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to adapt to the dynamic demands of modern healthcare. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address...
For companies focused on producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in better research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide.
In the March/April issue of Pharmaceutical Engineering, we dive into "The Workforce of the Future," highlighting a future-ready workforce, employee well-being, and a collaborative work environment in an industry dealing with a skills gap. Learn more about these and other issues in the current issue of the magazine.
Crafting and communicating a vision for the organization is one of the most important and visible jobs of a leader. It is also a difficult job, and executing plans to realize the vision is even more difficult.
The expectations for the workforce joining the industry right now are slightly daunting. It can feel like being required to be everything at once: flexible but driven by purpose, extremely adaptable but stable at the core, empathetic but independent, and knowledgeable but versatile.
Being a working mom has shaped my career in unexpected ways. Early in my career, a colleague who had just become a mother told me that you can’t “have it all”—a thriving career, a happy home life, and a fulfilling personal life.
