By Harry Benson and Aaron Roth
As pharmaceutical development and manufacturing processes become increasingly complex, optimizing facility and system management is more important than ever. Supply chain challenges in the COVID-19 pandemic have caused persistent external slowdowns. Novel therapeutic modalities such as cell and gene therapies have introduced new intricacies in pharmaceutical development and manufacturing. In light of these issues, it is vital pharmaceutical manufacturers remain dedicated to prioritizing operational readiness to prevent delays, lost product, and detrimental drug shortages.
Operational readiness and efficiency can be defined by the synergistic relationships between people, the plant, and its procedures. To achieve a sustained, reliable output of quality products, facilities should operate at the intersection of human performance and good engineering practice. However, meeting this balance requires leadership beyond the day-to-day operations of an active facility. A focus on system quality has to be integrated into the entire project life cycle in order to avoid startup delays, performance issues, batch loss, and unreliable output. This article will break down the broad impact of operational inefficiencies, how the role of system owner can make or break a facility’s operations, and what the reimagining of this role can mean for a treatment’s speed to market and subsequently, the speed to patient.
The Cost of Operational Inefficiency
The complexities of today’s pharmaceutical manufacturing landscape introduce new vulnerabilities to operational inefficiencies. Shortages of raw material ingredients for countless drugs and unreliable availability of timely shipping have contributed to unpredictability in production and, in turn, supply. These issues collide with internal challenges, as facilities must keep up with changing regulatory demands regarding process development, documentation, quality control, and data integrity. A lack of operational readiness can also compromise the performance of a facility’s staff, as poor organization and communication can lead to frustration and burnout. Maintaining consistent output of quality products is already challenging with these constraints, making it more critical than ever for companies to ensure their systems operate flawlessly.
But when project startup is delayed, manufacturing runs are invalidated, or gaps in operation occur, the operational inefficiencies often equate to both a financial loss and a loss that extends far beyond the facility. An unreliable output of a drug product translates to an unreliable supply for patients that need it most. When system improvements could truly mean the difference between life and death, how can companies gain steady control over the variables that impact productivity and quality?
A Pharmaceutical System Owner: A Traditional Perspective
Recently, the International Society for Pharmaceutical Engineering (ISPE) Baseline Guide 5: Commissioning and Qualification, 2nd edition, defined the system owner as “the person ultimately responsible for the availability, support, and maintenance of a system and for the security of the data residing on that system.” In the current pharmaceutical landscape, this definition falls short in its scope and vision.
This concept of system owner provides little connection between a facility’s engineers who develop a system and the system operators who continue its function. Because the demands of those engineering a facility differs widely from those involved in the ongoing, year-to-year operation of a GxP production facility, these activities are usually performed by entirely different teams. The traditional system owner role is often not brought onto the team until the facility is launched—it is treated as an afterthought. This ultimately contributes to haphazard operations and, as a result, poor productivity, batch failures, and release delays related to preventable deviations.
However, organizations can minimize these risks by leveraging the system owner role as a bridge that unites the project planning phase with ongoing operations through the entire life cycle of a system.
Reinventing The System Owner To Better Help Patients
What does a reinvention of the system owner role look like and how does it translate to better outcomes for patients? Rather than just a focus on the “availability, support, and maintenance of a system,” a reimagined system owner could be accountable for the operational readiness of a system from project to operations, with the stated goal of achieving maximum production quality.
This system owner would participate directly in the engineering process to develop and institute technical, procedural, and behavioral controls in the process design to frontload the identification of issues and minimize delays during handover and startup. For example, the system owner would understand, compile and, (if necessary) define the system user requirements, as well as own and maintain the traceability matrix. In doing so, they can anticipate system operational gaps rather than scrambling to fix issues in project startup, leading to a smoother transition from the engineering team to the operations team and avoiding issues later in the process.
A reinvention of the system owner role can also improve overall human performance by developing a detailed work breakdown structure for each specific system and facility design and layout early in the project phase, allowing a facility to hire, train, and qualify its staff in sufficient time to move directly into an operational state.
Avoiding drug shortages requires careful coordination of material supplies, system operations, and the staff powering a facility’s operations. Quality issues are the leading cause of drug shortages and will likely have a growing impact as production processes become more complex. Reframing the role of a system owner is a key investment in achieving sustained output of high-quality drug products. By coordinating system operations, anticipating issues, and ensuring appropriate distribution of resources at every stage of the project life cycle, a responsible system owner can play a vital role in ensuring that all patients can access the drugs they need, when they need them.
As the Global Director of Human Performance Services for Commissioning Agents Inc. (CAI), Benson leads a team of experienced professionals in developing and executing talent programs, processes, and tools with our clients. These services serve to standardize and improve the performance of their people by addressing challenges with organizations, work environments, leadership, and skill development programs.
As the Associate Director of Global Commissioning and Qualification, Aaron Roth leads his team in the fields of risk-based Commissioning and Qualification and Quality Risk Management (QRM). He has led the implementation of QRM principles on several large projects, as well as at the program level.