The US Food and Drug Administration's quality-by-design (QbD) initiative, a science- and risk-based approach to manufacturing,
adds another layer to the relationship between sponsor companies and contract manufacturers. Enhanced process understanding
is at the core of QbD, which is deepening the nature of outsourcing.
PHOTO: PASIEKA/SPS, GETTY IMAGES
A regulatory framework
At one level, QbD simply extends the collaborative nature inherent in an outsourced relationship. "Contract manufacturers
can apply the same mindset to process development and manufacturing as the sponsoring company. We encourage the use of quality
risk management for both design of the process-control strategy as well as for life-cycle management," says Christine M.V.
Moore, acting deputy office director of the Office of New Drug Quality Assessment in the Center for Drug Evaluation and Research
at the US Food and Drug Administration. "A large part of a QbD approach is enhanced understanding of the product and process.
This understanding should be openly communicated between the contract manufacturing organization and the sponsor such that
good science and risk-based decisions can be made."
A sponsor-company perspective
As drug companies adopt QbD in their own development and manufacturing, their expectations of contract-service providers are
changing. "There are several possible scenarios in which a QbD approach to development can impact the relationship between
a sponsor and a contractor," says Mary Oates, vice-president of global quality operations at Pfizer Global Manufacturing (New
York). The first scenario is when the sponsor is fully responsible for development and transfers the final process to the
vendor. A second scenario would be when the sponsor and firm collaborate on the development effort.
ICH Q10 Pharmaceutical Quality System and outsourcing
Under the first case, sponsors historically have interacted with contract-service providers to address quality, supply, and
technical needs and may also engage in continuous improvement activities. "These items will continue to be important, but
QbD will require far greater collaboration, beginning with the technical transfer and continuing as long as the contract-service
providers manufacture for the sponsor," says Oates.
She offers an example of that greater collaboration and the continual need to garner process understanding under QbD. "For
example, the contract-service providers must have full access to development data in order to understand the allowable design
space, and if and when changes can be made within this design space, to ensure the product remains consistent," she says.
"Once routine manufacturing begins, every lot that is manufactured becomes part of the overall body of knowledge, and the
data collected must be assessed to verify that the product and process are performing as expected. This involves much more
analysis than simply comparing results to a list of specifications. The contract-service providers must be capable of performing
and interpreting this analysis in a routine manufacturing environment, alerting the sponsor to any changes observed and ensuring
that required adjustments to the product or the process are implemented."
On the horizon...