Opportunities of Quality by Design (QbD)in Pharmaceutical development

Author: Heath Rushing
Critical Quality Attributes (CQA) is a property or characteristic that should be within an appropriate limit or range to ensure desired product quality, safety, or efficacy; it is used to guide product and process development. It identifies and ranks parameters with the potential to have an impact on product quality based on prior knowledge or initial experimental data.
1. Pharmaceutical Development
“Design of experiments or other experimental approaches could be used to evaluate the impact of the higher ranked variables, to gain greater understanding ofthe process, and to develop a proper control strategy.” This systematic understanding includes the following:identifying, through experimentation and risk assessment, the material attributes and process parameters that have an effect on product CQAsa determination of the functional relationships that link material attributes and process parameters to product CQAs.
2. Risk assessment and risk control
The risk assessment is used to help define the elements of the control strategy pertaining to materials from the drug substance. It includes an assessment of manufacturing process capability, attribute detectability, and severity of impact as they relate to drug substance quality.
3. Effective process validation
The goal of this stage is to design a process suitable for routine commercial manufacturing that can consistently deliver a product that meets its quality attributes, building or capturing process knowledge and understanding, establishing a strategy for process control.

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