The Quality Product Steward Model: The Genentech Approach - A successful QPS acts as a single point of contact for consistent product quality oversight. - BioPharm International


The Quality Product Steward Model: The Genentech Approach
A successful QPS acts as a single point of contact for consistent product quality oversight.

BioPharm International
Volume 24, Issue 2, pp. 30-42

Drug-Device Combination Products

Drug-device combination products have increasingly become a competitive edge in product marketing. The QPS, with comprehensive knowledge of the specific regulatory and GMP requirements for devices, plays an important role on the development team. In this regard, the QPS oversees the development of the design control strategy and assists the project team in the interpretation and implementation of design-control procedures. The QPS is responsible for initiating the design-history file, defining the design inputs, and creating and approving the design and development plan. During development, the QPS evaluates the prototypes, conducts risk analysis and design review, and accounts for risk management lifecycle activities. The QPS works in collaboration with external quality in ensuring adequate interface between the CMO's and Genentech's design history files.


Figure 2a. A quality product steward (QPS) business process diagram - 1
In order for the QPS to provide a consistent quality approach to project teams, we have developed business processes that standardize our key activities at each stage of clinical development. The business-processes include tasks, deliverables, timelines, roles and responsibilities, and decision points. These business process documents are incorporated into an online tool that has links to various templates, guidance documents, and folders. The standardized business processes have greatly improved the efficiency and consistency of the QPS function. It also serves as good training material for new QPSs and as a reference for other CMC functional areas so they have a clear understanding of the role of the QPS.

Figure 2b. A quality product steward (QPS) business process diagram - 2
Figure 2a and 2b are examples of QPS business process diagrams that describe the main flow of the quality-related activities and the QPS roles. Although the QPS oversees the overall quality activities during the process development, he or she also has specific responsibilities for key processes and documents (as highlighted in the diagram). For each of these specific activities, a detailed business process has been developed. For example, the business process for an expiration dating assignment (Table 2) specifies the step-by-step activities required, the deliverables, key stakeholders, end users, and timelines. The links to the templates and guidance documents are also included.

Table 2. Example of QPS business process: expiration dating assignment and extension for clinical products
The business process documents are living documents and are continuously evolving as gaps or opportunities for improvement are identified. In developing the business processes, the phase-appropriate GMPs for clinical product were applied. Establishing a new business process or changing an existing business process involves extensive discussions with the key stakeholders and end-users. The effectiveness of the business process is also monitored for its accuracy, consistency, and compliance with the Genentech quality systems (policies, standards, and standard operating procedures) and applicable regulations.


The quality environment during clinical development is much more dynamic than during commercial product manufacturing. The QPS is required to have both a basic understanding of GMPs and quality requirements, and the business and technical acumen to tackle various types of challenges.

As described above, the QPS role is quite different from other traditional quality functions. It requires a comprehensive skill set that not only includes scientific and quality-related knowledge and analytical thinking, but also requires competency in such skills as influencing, negotiating, problem solving, decision-making, collaborating, organizing, and project management, as well as the ability to manage many diverse issues at the same time. Prior experience as the quality decision-maker is very desirable.

Candidates with strong science and engineering backgrounds plus prior experience with process-development are very important as they are instrumental for the QPS to understand both quality and other process development issues. The individual with the aforementioned competencies are usually very successful in executing the QPS functions. The goal is to enable the QPS, who has experience in science disciplines, to understand other process development functions and instill scientific thinking into quality oversight and decisions. Although the combination of the above requirements may not be typical for personnel in a quality unit, we have been successful in recruiting many talented R&D scientists and managers from other quality and science functions with diverse expertise. Their prior experiences have proven to be extremely valuable in handling the QPS job.

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