7.2.1. For which products and from which phase on has QbD been established?

The 31 responses confirming that they had rolled out QbD by the summer of 2011 had done so to a rather different extent though. Many of them apply QbD only in some cases or some products, only for trouble shooting or in a model project and not as a systemic, integrated approach.

When asked from what stage of development on they apply QbD, out of the 31 only 4 stated to apply it for all development projects and variations in productions, seeing QbD as an integrated system not only for development but throughout the whole organisation. 12 answers stated to use it for all new developments irrespective of the dosage form and type of molecule, another 3 do so at least for all oral drug product developments and 1 response said to do it for all dosage forms except for biopharmaceuticals. 4 adopters apply QbD only in some cases, e.g. for trouble shooting, for a new technology, or as a model case and 1 company applies it only for life cycle management projects. 2 companies use it only for variations to existing market products and 4 for other cases, e.g. generic product development, some process development of API and drug product development, or for all projects but at a varying level.

This accumulates to more than a third (11 responses) out of all 31 QbD adopters, applying it still only partially or for specific projects.

There are also huge differences as to when QbD is applied during the development of a drug product or in a development project, i.e. at which stage of drug development QbD approaches will be started. Table 8 highlights this quite clearly, too. Most companies (> 50%) start using QbD only once a Proof of Concept has been reached for a project or product, with most of them defining this to be a clinical PoC. Less than 15% of all companies do start using QbD from the very start of their development activities for a new drug product.

Table 8: Responses to question 5 of questionnaire: “At which phase of drug development are you starting to use QbD?”