Bridging the Gap: Quality by Design as a Catalyst for Enhanced Quality Management Systems in Biopharmaceutical Manufacturing.

Shivang Saxena, Shubhi Saxena, Diksha, Niraj S Patil, Animesh Ranjan, Amandeep Singh
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Abstract

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.

缩小差距:质量源于设计--生物制药生产过程中质量管理系统提升的催化剂》(Quality by Design as a Catalyst for Enhanced Quality Management Systems in Biopharmaceutical Manufacturing)。
该文件强调了解决质量管理体系(QMS)中的关键问题的重要性,以便在充满活力的市场中保持竞争力并提供高质量的产品和服务。文件强调了采用新型质量管理技术以取得长期成功的必要性。书中讨论了质量源于设计(QbD)的基本原理,并追溯到约瑟夫-M-朱兰(Joseph M. Juran)等先驱以及有效实施六西格玛(Six Sigma)的概念。QbD 被描述为一种系统方法,重点关注风险管理、质量目标产品简介 (QTPP) 和关键质量属性 (CQA),以创造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。制造商可以灵活运用 QbD,同时仍然遵守严格的质量标准。它标志着行业范式的改变。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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