Quality by design (QbD) principles are increasingly being employed during design and development of manufacturing processes to gain enhanced product and process understanding and to ensure that the commercial manufacturing process delivers product with a predefined quality. Implementation of QbD principles requires defining acceptable ranges for product's critical quality attributes (CQAs) and performing process characterization studies to determine acceptable process parameter ranges that ensure that the CQA acceptable ranges are met. The acceptable process parameter ranges can then be proposed as part of a design space claim where movement within an approved design space is not considered a change as defined by ICH guidance Q8(R2) and Q11. Although ‘a process-wide’ design space can provide maximum flexibility, there can be drivers for unit operation specific design spaces that only include a subset of process parameters depending on the type of operational flexibility desired, process capability, and potential for meeting acceptable product quality during worst-case process linkage. This talk will review selection criteria in determining the type of design space claim to be pursued and discuss the advantages and challenges in implementation of an upstream only design space including implications to parameter movement within the design space and impact to the control strategy.

Design space assessment focused on value and probability of success

249th National Meeting (2015)

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