7.1. Questionnaire to obtain feedback about the current status, reasons for and benefits out of ObD implementation in the pharmaceutical industry

The questionnaire was filled in by companies developing either proprietary or generic drug products, drug/device combination products or doing contract research developing and manufacturing drug products for their clients. For all categories, drug products for small chemical molecules and biopharmaceuticals, i.e. biologically manufactured compounds are included in the results. While most participating companies focus on small molecules (highest percentage of answers) some answers also refer to biopharmaceuticals and then many of these are additionally also developing drug/device combination products. Out of the total of 39 responses the split was as listed in Table 6, which highlights the multiple focuses of most companies. While the majority of participating companies do focus on the development of small chemical molecules (80%), most of them do also develop drug / device combination products. Most of the companies developing biopharmaceutical drug products also develop drug / device combination products. Some companies even develop all types of products, small chemical molecules, biopharmaceuticals, and drug / device combinations for both types of molecules. Out of the 39 companies 10 develop either exclusively or also for clients or to out-license their products.

No direct differentiation was made as to proprietary or generic drug products, but 2 companies stated explicitly to work on the development of generics.

Table 6: Responses to question 1 of questionnaire: “Which types of drug products does your company develop? (Please, tick all applicable categories)”

Out of the 39 responses only 9 companies had started to roll out QbD before 2008, while the majority i.e.16 companies started between 2008 and 2010 and another 6 have started just recently in 2011, adding up to a total of 31 adopters out of 39 responses.

8 companies, i.e. more than 20% of all responses had not yet started a roll out by summer 2011 despite the additional guidance, points to consider and presentations from the ICH
working group – and at least 3 of those stated that they do not plan to roll out QbD at all.

Out of the 8 companies, that had not started rolling out QbD only 3 companies were developing for others. Those were the same 3 that did not plan to roll out QbD at all applying elements of QbD only if requested to do so by their customers.

Even though the responses in the survey may contain more than one response from each pharmaceutical company because of the methodology of anonymous replies via the internet, the result obviously confirms that the industry has by far not embraced QbD in a widespread manner yet. Surprisingly, so far this does not only apply to CROs or generic companies, some of which have actually started to apply QbD concepts to some extent, but also to proprietary companies.

All further questions apply only to the adopters of QbD and therefore those 31 responses account for 100% for all evaluations in the following tables.

The companies that started to adopt QbD, do so employing a rather wide range of the elements and tools of QbD, as depicted in Table 7.

Table 7: Responses to question 6 of questionnaire: “Which elements or parts of QbD have you established so far? (Please, tick all appropriate answers)“

This clearly shows that even among those companies, that have rolled out QbD, this has been done at a rather different extent. The biggest majority of all companies use only some of the tools still lack the integrated approach of PQS and QRM systems as requested by ICH Q9 and Q10. While QbD tools, such as PAT, DOEs, QTPPs, and joint risk analyses in the project teams seem to be used in about two thirds of the companies only half of all companies have actually established a PQS and QRM as integrated processes, and still refer to a traditional Control Strategy based on specifications only. Continual Improvement and Knowledge Management as the essential basis for ongoing learning and progress has rarely been established at all. Less than 30% of all adopters pursue a systematic Continual Improvement and even less than 15% have set up a systematic Knowledge Management at all.

This demonstrates clearly, that even if companies have rolled out QbD for all of their development activities most of them still miss out from the benefits of the new paradigms as provided by fully integrated processes and systems within the corporate structure and culture.