Putting the Quality in QbD

In the previous post, I laid out an example of how to begin documenting the QbD process.  Over at LinkedIn, there's a discussion about the challenges of bringing a QbD/PAT program into existence that is really worth the read.  My plan for this entry is to outline some of the pathways that need to be in place for QbD to be effective and deliver on its promises.

I believe the important, and obvious, starting point is in the Q of QbD.  The agency's have clearly articulated their expectations through the guidelines (see link to the right).  What are the practical implications of these?  Paperwork.  We have to work with the quality systems to enhance, or build, the infrastructure to support a QbD approach.  For example, there are lots of examples of risk analysis in the literature; however, the approach has to be coded into the quality system to ensure that people are appropriately trained in the methodology and the results documented, reviewed and filed within the quality system for reference.  For pharmaceuticals and biopharmaceuticals, the risk assessment has to be phase appropriate and continuous: what is done for phase 1 is not what is done for phase 3/validation and the risk analysis should evolve as a program pushes through from phase 1 to phase 3.  Oh, the QbD process also has to be flexible to handle in-licensing of a product.  All of this, and more, represent the foundation of a solid QbD program.

What does this mean on the day to day?  The lines of communication to the various quality groups have to be reinforced every day.  Conversations over a cup of coffee, formal strategy meetings, and more all serve to develop those relationships that will enable the organization to leverage its knowledge effectively and efficiently.