QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work - The focus on the design space will lead to a new workspace, and will affect staff in the development, manufact


QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work
The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

BioPharm International
Volume 22, Issue 11


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 analytical understanding
  • 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 support.

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,


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.

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