Saxena Shivang, Saxena Shubhi, Patil Niraj S, Ranjan Animesh, Singh Amandeep
Department of Regulatory Affairs, ISF College of Pharmacy, Moga, Punjab, 142001, India.
Department of Quality Assurance, ISF College of Pharmacy, Moga, Punjab, 142001, India.
Curr Drug Discov Technol. 2025;22(4):e15701638312326. doi: 10.2174/0115701638312326240918093333.
The document emphasizes the importance of addressing key issues in Quality Management Systems (QMS) to stay competitive and provide high-quality goods and services in a dynamic market. It highlights the need to adopt novel quality management techniques for long-term success. The fundamentals of Quality by Design (QbD) are discussed, tracing back to pioneers like Joseph M. Juran and the Six Sigma concept for effective implementation. QbD is described as a systematic approach focusing on risk management, Quality Target Product Profile (QTPP), and Critical Quality Attributes (CQAs) to create products meeting predetermined quality standards. QbD incorporates quality concepts into the development and production processes. Its goal is to guarantee the quality of the product by determining and managing important factors. Manufacturers can be flexible with it while still adhering to strict quality standards. It signifies a change in the industry's paradigm.
该文件强调了在质量管理体系（QMS）中解决关键问题对于在动态市场中保持竞争力并提供高质量产品和服务的重要性。它突出了采用新颖质量管理技术以实现长期成功的必要性。文中讨论了设计质量（QbD）的基本原理，可追溯到像约瑟夫·M·朱兰这样的先驱以及用于有效实施的六西格玛概念。QbD被描述为一种系统方法，专注于风险管理、质量目标产品概况（QTPP）和关键质量属性（CQA），以创建符合预定质量标准的产品。QbD将质量概念融入开发和生产过程。其目标是通过确定和管理重要因素来保证产品质量。制造商在遵循严格质量标准的同时可以灵活运用它。它标志着行业范式的转变。
