Three World-renowned experts – Bikash Chatterjee, President and CSO, Pharmatech Associates; Emil Ciurczak, President at Doramaxx; and Brian Carlin, Director Open Innovation at FMC – look at the implications of QbD, continuous processing, excipient criticality, and process validation on pharma manufacturing.

The overall findings reveal there is clearly now a global commitment to move forward with the principles of QbD, however, the rate of adoption remains highly uneven. At the advanced end of the spectrum there are a limited number of Western manufacturers that are moving towards continuous processing. However, underestimating the complexity of both raw materials and finished products will continue to breed Black Swans, which could be particularly detrimental to continuous manufacture with real time release.

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