Kaleem Abdul M, Koilpillai Jebastin, Narayanasamy Damodharan
Pharmacy, SRM Institute of Science and Technology, Chennai, IND.
Pharmaceutics, SRM Institute of Science and Technology, Chennai, IND.
Cureus. 2024 Aug 30;16(8):e68215. doi: 10.7759/cureus.68215. eCollection 2024 Aug.
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.
本文旨在介绍风险评估的理念和工具，这些理念和工具可用于应对各种药品质量挑战。这些要素涵盖了药物原料、药品和生物制品在其生命周期各阶段的研发、生产、分销、检验以及审评程序报告。鉴于确保药品有效性、安全性和质量的持续要求，制药行业一直在不断发展。在这种动态环境中实现卓越制药的一项关键策略是采用诸如质量源于设计（QbD）和风险评估等新方法。风险评估是一种系统策略，用于识别、评估并降低药品生产和研发过程中的任何风险。另一方面，QbD原则更强调最终产品检测，并将其置于从一开始就将质量设计到产品中的背景下。本文的主要目标是探讨和研究风险评估方法与QbD原则工作流程的整合，以确保药品质量。对近期有关风险评估在制药领域应用的文章进行了评估。为提供有用的概述，突出了各种评估方法，强调了它们的优缺点。
