QbD at work
: Do you have an example from your own work in which QbD came into play as part of an outsourcing project?
We have examples where clients have asked us to develop their 'to-be-marketed' formulations. It has been clear from the start
of some projects that a QbD approach was desired, so formulation development, analytical development, and process scale-up
were all conducted using risk assessment and DoE processes.
We are in the final phase (NDA submission) of a QbD project for a new customer in which we provided full formulation, finish
dosage, and scale-up activities for a new molecule. The QbD activity was very successful for our customer. We collaborated
to identify critical quality characteristics as well as critical process parameters, conducted multivariate analysis, and
established in-process specifications to ensure robustness during manufacturing as well as all requirements for the NDA filing.
: IRIX provided development and manufacturing services for a project using QbD principles to develop and assess risk for manufacturing
of a Phase III development API. In preparation for a registration campaign, a two batch demonstration campaign was planned.
Prior to the demonstration campaign, IRIX conducted a proven acceptable range (PAR) study for optimization of a hydrogenation
step using a new catalyst identified through screening by the catalyst manufacturer. The PAR study compared the process performance
of the new catalyst in reaction conditions designed to model the manufacturing process and equipment while using the previous
catalyst as a control. IRIX also worked with the client to conduct studies using failure mode and effects analysis (FMEA)
of each process step and to incorporate recommendations from those studies in the batch records for the demonstration campaign.
A further set of FMEA studies will be conducted prior to the registration campaign using the data collected during the demonstration
campaign as well as continued research and development laboratory studies into key areas of concern relative to process control