Quality by Design: A systemic approach to process development


Upadhya Timmanna, Senior VP Biopharma Services, Eurofins CDMO India (Eurofins Advinus Limited), explains

Quality by Design (QbD) is an essential concept that one should apply during the development of drug substances that are in late-stage clinical trials. By deploying a QbD approach, Eurofins CDMO enables clients to build the required quality into the product during the design and development phase by understanding the effect of material attributes and process parameters on Critical Quality Attributes (CQAs).

Eurofins CDMO’s approach typically includes: setting quality objectives (QTPPs); identifying CQAs; prioritising process parameters and material attributes using Failure Modes and Effects Analysis (FMEA); screening Design of Experiment (DOE) to derive Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs); optimisation using Response Surface Methodologies (RSM); arriving at design space; and lastly, control strategy to regulate CPPs in order to achieve high process capability.

Eurofins CDMO strongly believes in the importance of effective QbD during the process development and involves a cross-functional team of analysts, process engineers, quality assurance, sourcing and manufacturing that helps all to consider right input variables during designing and developing the process. Cumulative wisdom of the brainstorming team during FMEA ensures more robust processes and methods, resulting in improved efficiency, reduced risk and fewer failures. This also enables the team to achieve one of the elements of ICH Q10: continual improvement within the boundaries of design space with minimum regulatory consent to the customer.

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