Mastering Quality: Uniting Risk Assessment With Quality by Design (QbD) Principles for Pharmaceutical Excellence

The aim of this article is to present ideas and tools of risk assessment that can be implemented to overcome various pharmaceutical quality challenges. These elements cover the development, production, distribution, inspection, and reporting of review procedures for drug substances, drug products, and biological products at every stage of their lifecycle. In light of the constant requirement to ensure the drug's efficacy, safety, and quality, the pharmaceutical sector is always evolving. A key strategy for attaining pharmaceutical excellence in this dynamic environment is incorporating novel methods like quality by design (QbD) and risk assessment. Risk assessment is a methodical strategy to locate, assess, and minimize any risks in the manufacturing and development of pharmaceuticals. On the other hand, QbD principles place more emphasis on end-product testing and place it in the context of designing quality into the product from the beginning. The major goal of this paper is to address and examine the integration of risk assessment approaches with the QbD principle workflow to ensure pharmaceutical quality. Recent articles on how risk assessment has been used in pharmaceuticals were evaluated. To provide a useful overview, the various assessment methodologies have been highlighted, emphasizing their benefits and drawbacks.