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.
QPS BUSINESS PROCESSES
Figure 2a. A quality product steward (QPS) business process diagram - 1
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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
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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
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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.
QPS QUALIFICATIONS
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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