Application of Quality by Design to Inhalation Products
Bowles N, Cahill E, Haeberlin B, Jones C, Mett I, Mitchell JP, Mueller-Walz R, Musa R, Nichols SC, Parkins D, Petersson GI, Preissmann A, Purewal TS, Schmelzer C.
RDD Europe 2007. Volume , 2007: 61-70.
Abstract:
This paper describes the driving forces behind efforts to adopt QbD in the pharmaceutical industry. Industry surveys have shown that the primary reasons for adopting QbD are to improve product quality and understanding while the increased workload associated with the effort was cited as the greatest obstacle to its enactment. The paper also describe the steps necessary to gain approval for freedom of operation within design and/or control spaces for a theoretical pMDI that has been developed in accord with the principles of QbD.
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