THE QPS BUSINESS MODEL
The difference between the QPS role and the quality control (QC) or quality assurance (QA) functions is that this job is not
purely function-focused. It is centered on all aspects of product quality and product knowledge, and on being the single point
of contact for communication and accountability.
It is important for the QPS to be involved when the product enters development, before toxicology campaigns, and to stay with
the product as it moves through development. Early involvement by one person from quality who is knowledgeable of the product
and its challenges provides a proactive front-end approach to quality, as opposed to the traditional reactive back-end approach.
Typically QC and QA become involved after the manufacturing process has been developed and the product is manufactured. It
is the responsibility of the QPS to ensure quality is ingrained and built into the process during development. The QPS can
foresee and inform the project team of potential product quality issues during process development, manufacturing, testing,
and management of investigations/discrepancies, and can provide strategic direction and decisions to the project team. The
combined knowledge of the product, processes, and the quality functions makes the QPS the best decision-maker for the product's
quality. When resolving a critical quality issue, the QPS does, however, engage the appropriate quality function and upper
management to ensure a sound decision is made and issue resolution occurs.
A biopharmaceutical product can take up to 10 years from initial development to approved commercial product. Along the way,
many key functional areas such as process, analytical, and pharmaceutical development have generated and accumulated extensive
product-specific knowledge. The importance and value of this knowledge are critical and indispensable for understanding a
product and developing a high-quality manufacturing process.
There is also value in generating product-related quality knowledge during the development lifecycle. Although product-related
quality knowledge is not as well defined as other scientific disciplines, it can be considered an interdisciplinary knowledge
encompassing product characteristics and development history; and how the physico-chemical characteristics and manufacturing
process of products are linked to their quality attributes. It is also about knowing stability profiles, specifications (including
methods and acceptance criteria), released batches used in various clinical trials (including Certificate of Analysis results
and stability data), and major quality-related investigations and discrepancies. In addition, the product-related quality
knowledge also includes quality and cGMP principles and systems and relevant regulatory guidelines. The product-related quality
knowledge gathered during clinical development is extremely valuable when developing the commercial manufacturing process
and setting the final control system.
Because the QPS stays with the product from initial development to commercialization and serves as the single point of contact
on the project team, they accumulate a vast amount of product knowledge. Clinical development is a very dynamic environment
that requires versatile skills and knowledge. The product knowledge gathered provides the QPS with a solid product history
and strategic thinking in the quality approach to deal with the constant changes that occur along the way.
QPS ROLES AND RESPONSIBILITIES
The creation of the clinical QPS at Genentech was the result of a business need and experimentation with a new quality concept
to ensure consistent and effective quality oversight during clinical development.
Table 1 lists the main roles and responsibilities we have identified as value-added services and tasks that benefit process
Table 1. The quality product steward's (QPS) roles in various CMC-related tasks
As stated earlier, the QPS is involved in the project team's activities early on in development. During GLP toxicology study
stage, our QC is normally responsible for testing and releasing the material. The QPS authors the characterization protocol
that defines test methods and acceptance criteria. Subsequently, the QPS also drafts the stability testing protocol when the
toxicology study is complete to ensure the material used has been stable throughout the study period. Although the material
manufactured may not be GMP, it is often considered representative of Phase 1 clinical material. In this situation, the QPS
serves as a central role on the project team, accountable for the generation, release, and maintenance of the reference material.
Their guidance and communication provided to the project teams and quality functions is very valuable.