TRAINING FOR NEW WAYS OF WORKING
These changes in the ways various functions do their part in ensuring GMPs will require additional training, which under ICH
Q7 is itself a GMP.1 Different functions will, of course, require different kinds of training. For example:
- QC staff will need training in PAT technology and strategy and in complex upstream analytics.
- QA and manufacturing personnel will need training in risk-based assessment and compliance, and in appropriate process and
- Development staff will need help with DOE, and effective, or even compliant, documentation, and manufacturing constraints
such as cost-of-goods efficiencies, GMPs, and risk analyses.
But the convergence of science and compliance in QbD lends a common theme to all such training: the understanding of the design
space. For some personnel, that will mean understanding the design space conceptually and, in specific instances, knowing
the relevant parameters for purposes of control and the like. For others, particularly those who actually determine the design
space, it means familiarity with the advanced statistical methods that are used to map the complex relationships among product
quality attributes, the manufacturing process, and clinical safety and efficacy, and to determine the various permutations
of critical input variables that will keep the product within specifications.
It is precisely because biological processes involve many raw materials, numerous upstream and downstream processing steps,
numerous types of equipment and operating conditions, and high levels of variation that the analytical and statistical rigor
of QbD are required for designing highly robust and reliable systems. Many biopharmaceutical companies already use many of
these statistical tools but not necessarily in a full-fledged QbD program. However, these tools are rarely subject to compliance
oversight, and they are not easily amenable to the current procedural GMPs practiced in most biotech companies.
Achieving GMPs in a QbD environment will also require that personnel from diverse functions learn how to work in crossfunctional
teams. Such teamwork will be required to ensure product quality and that each function achieves some degree of crossfunctional
understanding. For example, development, IT, and statistics personnel will need an appreciation of GMPs, while the quality
and manufacturing groups ensure that the spirit of GMPs is captured as part of the project and lot histories. If effective
and accountable team leaders are deployed, then crossfunctional teams can function smoothly as long as they have management
In essence, the focus on the design space leads to what we might call a new workspace. Crossfunctional teamwork, the changing
focus of work in specific functions, and a more holistic approach to quality are all part of this new workspace. Just as science
and compliance converge in QbD, teams, functions and organizational processes will converge in this new workspace to realize
the vision of more efficient development and production of biopharmaceuticals.
Chester A. Meyers, PhD, is a managing consultant, and Debbie Weigl is a senior consultant, both at Tunnell Consulting, King of Prussia, PA, 610.337.0820, firstname.lastname@example.org
1. International Conference on Harmonization. Q7. Good manufacturing practice guide for active pharmaceutical ingredients.
Geneva, Switzerland; Nov 2000, p. 6
2. International Conference on Harmonization. Q8(R2). Pharmaceutical development. Geneva, Switzerland; Nov 2005, p. 11.
3. US Food and Drug Administration. Guidance for Industry. PAT—A framework for innovative pharmaceutical development, manufacturing,
and quality assurance. Rockville, MD; 2004.