7.2.4. QbD Integrated Supply Chain?

Pursuing QbD as an integrated approach is essential to fully benefit from this shift of paradigms, but this also includes the complete supply chain (as also needed for TQM), including suppliers of raw materials, contract research organisations or manufacturers to which all or part of the manufacturing has been outsourced and of course all internal functions of the supply chain starting at R&D and carrying on into the commercial scale production of drug products.

However, only 12 responses out of 31 adopters of QbD stated to have included their suppliers and CROs/CMOs into this approach with not all of them having done it for both. Internal integration of the value chain functions and supporting functions, has been achieved at a wider extent (18 positive responses), which is however, still often limited to the technical development functions (4x) and/or production (3x) only.