Looking back at our experience with the QPS role, its evolution seemed natural, a result of addressing a rapidly increasing
clinical product pipeline, the diverse nature of our biopharmaceutical products, an expanded global network, and greater outsourcing
strategies. Although the QPS is relatively new, so far our experiment in the clinical quality organization has been well received
by both the project teams and many of the quality groups, achieving a win-win for both sides. For the project teams, one owner
is identified to oversee the quality activities and address quality issues. For the quality organization, the QPS allows a
harmonized and consistent quality approach and prevents communication gaps. Additionally, it reduces the requirement of quality
One of the valuable lessons learned is that it is very important to clearly define the scope of QPS responsibilities. At the
early stage of implementing the QPS model, there was some confusion about QPS job functions. As a result, people were hesitant
to accept the QPS role. To address the situation, we spent a significant amount of time with the key stakeholders to define
QPS roles and responsibilities, discussed concerns and questions openly with various partners and customers, and finally reached
a business agreement. Then, we did road shows to convey a consistent message about QPS. In the meantime, we kept our focus
on the project and customer needs, and successfully helped the project teams resolve many important issues.
One good example of such success is a product specification file (PSF). As our clinical trial became more global, different
requirements for releasing clinical material from various countries became apparent and needed to be addressed in a consistent
way. In EU countries, QP release of investigational medicinal product (IMP) requires PSF. This document contains key product
information from manufacturing, analytical methods, stability to clinical protocol, and shipping and handling conditions,
among other information. At the time, there was no such document for our products and no functional group was taking responsibility
for it. We identified the gap, seized the opportunity, and subsequently created PSF with the standard content and format.
QPSs have comprehensive product quality knowledge and become the natural owners of the PSF. Now the PSF document is fully
implemented for every clinical product. It is not only used for EU release, but also acts as a useful single-source document
containing all the key information about a product manufacturing profile.
Another success example is the QPS role in change control (CC) process. Process change during clinical development is typical
for biopharmaceutical products. Evaluating and documenting these changes can be very daunting. When the CC process was initially
started by the clinical organization, the QPS took the initiative in helping project team and QA groups defining detailed
business processes and instructions for each type of change. In the end, transitioning to the new CC had minimal impact to
the project timeline. Here, the QPSs used their combined knowledge in product development and GMP compliance to benefit project
Through many of the success stories, the project teams and various functional groups recognized the values of QPS and began
to accept and value the QPS role and contribution. Now it has become natural that when a new CMC project team kicks off, the
team requires a QPS as a formal member. At Genentech's technical development area, we embrace an efficient decision-making
process. This culture is also conducive to QPS success because the QPS's quality and product knowledge enables timely decisions
on the quality aspects during product development.
From our perspective, this QPS concept may have utility for other established biotechnology and pharmaceutical companies.
For other companies (such as small companies) that are resource conscious, having a quality SPOC on their project team may
also add value because the efficiency aforementioned is a key aspect of such a role. We also acknowledge the challenge in
implementing the QPS role, because it is not a traditional quality function and may require significant effort in defining
its roles and responsibilities. It is important that the QPS's specific job functions are adjusted to the organization's needs
and process development philosophy.
In the current competitive pharmaceutical development environment, being adaptable and agile can be critical to success. In
this article, we introduced a new concept and role in quality that emerged from our business needs. The dynamic role that
the QPS plays requires him or her to maintain a quality philosophy that is compliance conscious, flexible, and scientifically
based. The key to being a successful QPS is to act as a single point of contact for consistent product quality oversight and
to maintain product knowledge while helping project teams achieve their goals.
We would like to acknowledge Gail Burnett for proposing and supporting the QPS model, and her critical review of the manuscript.
We sincerely thank all the past and current staff members in our department (IMP Quality—Biologics) for contributing to the
establishment and acceptance of this new role at Genentech, making it a critical and successful CMC function during clinical
Zhengyu (Jerry) Dong is a senior manager, Sharon Ma, PhD, is a senior QPS, and Dian Feuerhelm is director, IMP Quality- Biologics, Pharm Technical Development, Genentech, A Member of the Roche Group, South San Francisco,
CA, 650.225.6747, firstname.lastname@example.org
1. Steven, SE. Process Development: Think Like a Scientist—Behave Like a Business. BioPharm Int. 2007;20(8):40–7.