The quality product steward (QPS) model, a single point of contact model, was created at Genentech to manage the quality of our clinical products. The purpose of the QPS is to provide quality oversight and a single and consistent quality approach for our CMC (chemistry, manufacturing, and control) teams. The QPS function enables efficient communication and decision-making related to the quality of our products to occur. The QPS performs many key quality tasks supporting GMP manufacturing, product testing and release, regulatory filings, and clinical supply. The QPS acquires product-quality knowledge and acts as the quality expert for the product-quality history throughout the development cycle. This model has been implemented in our clinical quality organization for more than three years and proven to be valuable to both project teams and the quality organization during clinical product development.
Since the first recombinant DNA product based on human growth hormone was successfully approved and launched in the mid-1980s, the biopharmaceutical industry has evolved tremendously. Significant advances have been made in manufacturing technologies and analytical and pharmaceutical sciences. Additionally, the global regulatory environment has been constantly evolving. In the last two decades, the compliance environment has grown ever more complex. The pharmaceutical industry is facing increased expectations; and delivering products that meet the global regulatory requirements is becoming more complicated and challenging. In today's drug development environment, research and development (R&D) is not the only critical player that can help a company gain a competitive edge. Other supporting functions such as a quality organization with agile and flexible business processes also contribute to the speed of the development timeline and quality of drug development as well.
At Genentech, we constantly improve our business processes to enhance efficiency and productivity in all chemistry, manufacturing, and control (CMC) functional areas.1 This is especially important in light of our significant clinical pipeline, the diverse nature of our biopharmaceutical products such as monoclonal antibodies (MAb), MAb-drug conjugates, and drug-device combination products, and the number of global sites and outsourcing activities involved during clinical product development at Genentech. The fast-paced and dynamic environment prompted Genentech's clinical quality organization to reevaluate its business model around quality representation on the technical and manufacturing development team (TDT or project team). As a result, a new functional role, the quality product steward (QPS), was established in Genentech's clinical quality organization.
The QPS represents all of the quality functions on the project team to enable quick and effective decision-making and to ensure that the quality of a released product meets predefined quality requirements (i.e., specifications). In this article, we will describe the rationale for establishing the QPS role, our experience, and its success.
GMP QUALITY DURING DEVELOPMENT
Process (i.e., CMC) development is a critical function in pharmaceutical drug development. To manage the many diverse aspects of process development, a project team is formed that consists of representatives from several key functional areas including process development, analytical development, pharmaceutical development, manufacturing, quality, and regulatory affairs (Figure 1). At Genentech, the quality function includes several functional groups that focus on specific quality aspects such as raw materials, environmental monitoring, in-process testing, drug substance and drug product testing, viral and mycoplasma testing, quality systems (e.g., documentation, change control), and quality assurance. All of these functions contribute to the process development of clinical products. Their activities must align with the timeline and overall deliverables of the development goals. As Genentech's product pipeline grew and became more diverse, having a representative from each of the quality function groups on the project team became unrealistic and unfeasible.
Figure 1. A project team consists of representatives from several key functional areas
Creating a single quality representative, who provides effective and efficient quality feedback, ensures consistent and cohesive quality oversight. Thus, the QPS role was created. A QPS is assigned to a project team and stays with the project from preclinical development to product launch. Then, the QPS hands the product's quality oversight responsibilities and its development history to the commercial quality steward, who shepherds the product through the commercial environment.
One of the immediate benefits in creating the QPS role was the reduction of resources needed in the various quality functions. This role also greatly helps the project team by identifying a single point of contact that is accountable for all quality issues. The QPS serves as a quality expert for the product during clinical development and is responsible for making quality-related decisions and playing the role of the liaison between the project team and other quality functions. This model provides a consistent quality voice on the project team and helps the team to reach decisions more effectively and quickly. One QPS can provide quality oversight for two to three products, depending on the development phase and level of complexity of the products. In the following sections, we will describe the QPS role in detail, the responsibilities of the QPS, and the business processes that support the QPS function.