8.2. McKinsey’s description of obstacles to the widespread implementation of QbD

The “10 key challenges” in Figure 14 they had identified back in 2009 were considered to be caused partly by the companies themselves but to a big extent also by the regulatory bodies.

Figure 14: 10 key obstacles to a widespread implementation of QbD according to McKinsey’s report in 2009 Current interaction with companies is not conducive to QbD⁷⁷

From my own survey in 2011 most of these obstacles are still very relevant and it appears that they have not been improving significantly over the last 2-3 years. The lack of technology to execute QbD and internal misalignment seem to be less relevant today, while the inconsistency of handling of QbD applications and perceived benefits – especially in an international regulatory environment – still appear to be quite significant. The lack of belief in the business case is thus more a result than a cause of the still lacking widespread adoption of QbD.

⁷⁷ Source: Fuhr; State of Implementation; 2011; slide 11 (slightly adapted)