a School of Pharmaceutical Sciences , Lovely Professional University , Phagwara , Punjab , India.
b Product Development Cell 2 , National Institute of Immunology , New Delhi , India.
Expert Opin Drug Deliv. 2018 Aug;15(8):737-758. doi: 10.1080/17425247.2018.1504768. Epub 2018 Aug 3.
Quality by design (QbD) encourages the pharmaceutical industry to use risk management and science-based manufacturing principles to gain process and product understanding and thus assures quality of the product. With the objective to curb the rising costs for development and regulatory barriers to innovation and creativity, QbD is being widely promoted by Food and Drug Administration (FDA) and International Conference on Harmonization (ICH).
This review describes the elements, different design and tools of QbD as well as multidimensional applications of QbD ranging from dosage form and method development to meeting latest regulatory requirements.
The understanding of a process is facilitated by proper identification of sources of variation, management of variability by process design, and prediction of product quality attributes using design space. The pharmaceutical industry is rapidly adopting the QbD principles for fabrication of safe, effective and quality products; however, we are still on a journey and the process of gathering all experience and metrics required for connecting and demonstrating QbD benefits to all stakeholders is still in progress. Understanding the formulation and process parameters with the philosophy of QbD will be useful for the optimization of complex drug delivery systems in the near future.
质量源于设计（QbD）鼓励制药行业运用风险管理和基于科学的制造原则来深入了解工艺和产品，从而确保产品的质量。为了遏制不断上升的开发成本以及创新和创造力方面的监管障碍，食品和药物管理局（FDA）和人用药品注册技术要求国际协调会议（ICH）正在大力推广 QbD。
本文综述了 QbD 的要素、不同的设计和工具，以及 QbD 的多维应用，涵盖从剂型和方法开发到满足最新监管要求。
通过正确识别变异源、通过工艺设计管理变异性以及使用设计空间预测产品质量属性，有助于加深对工艺的理解。制药行业正在迅速采用 QbD 原则来制造安全、有效和高质量的产品；然而，我们仍在探索之中，收集将 QbD 优势连接并展示给所有利益相关者所需的所有经验和指标的过程仍在进行中。了解基于 QbD 理念的配方和工艺参数将有助于在不久的将来优化复杂的药物传递系统。
