Now that QbD is firmly entrenched within our industry (could we have said that confidently a year or two ago?), manufacturers, regulators, and assorted thought leaders have their sights set on next steps for the movement:
- continuing to build the collection of case studies to serve as models for industry to follow, and fleshing out the literature on the topic
- clarifying the business case for QbD (For a dizzying discussion on this topic, see this recent thread on our LinkedIn group.)
- honing ideas of how QbD is best applied in given situations or niches (e.g., QbD for generics: here’s another LinkedIn-thread-gone-wild on the Quality-by-Design group)
- reevaluating “conventional wisdom” in regards to QbD’s ultimate objectives and benefits
To this last point, one piece of conventional wisdom has held that QbD is about getting to market faster—even as quickly as possible. It makes sense on the surface.
But in the cover story of Pharmaceutical Manufacturing’s November/December issue, Tunnell Consulting’s J. Paul Catania takes issue with that premise. QbD “isn’t about getting to market fast; at least not directly,” he writes. “QbD is about getting to market reliably. QbD is about knowing enough about the limitations and risks associated with formulation and production methods in order to establish appropriate mitigation and contingency plans. Organizations that go to market fast with limited formulation and process knowledge risk disruptions whose cost and time losses will quickly outstrip the advantage of being there early.”
Catania presents a case study of one company which experienced such a fate, that lacked sufficient formulation and process knowledge and was forced to enact stopgap measures to fix commercial production issues. “So, here is where QbD reenters the conversation,” Catania continues. “Quality by Design is nothing more than risk mitigation through process understanding. It’s pretty obvious that the earlier in development and commercialization that this process understanding occurs, the sooner the risk is quantified and, if not mitigated, at least understood such that appropriate management and cost allocation contingency plans can be put in place. This case illustrates the painful and multiple collateral effects across the organization when risk ends up being identified through unplanned failure.”
Catania’s is an important article that explores in-depth what time to market (or speed to market) really means.
It also illustrates the maturation of Quality by Design and how the “regulatory” aspect of the initiative has become less of a preoccupation. For what it’s worth, Catania mentions “FDA” just one time in the entire article.
Again, here’s “QbD: Redefining Time to Market” on PharmaManufacturing.com.
–Paul Thomas
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