弥合差距:设计质量作为生物制药制造业增强质量管理系统的催化剂
Shivang Saxena1, Shubhi Saxena2, Diksha2
1Department of Regulatory Affairs, ISF College of Pharmacy, Moga, Punjab, 142001, India.
Current drug discovery technologies
|October 1, 2024
概括
采用新的质量管理技术,如Quality by Design (QbD),对于企业保持竞争力和确保高质量的产品至关重要. QbD侧重于风险管理和关键的质量属性,以实现长期成功.
科学领域:
- 质量管理质量管理.
- 制药发展 制药发展
- 工业工程 工业工程 工业工程
背景情况:
- 现代市场需要不断改进质量管理系统 (QMS),以保持持续的竞争力.
- 传统的质量控制方法在需要创新方法的动态市场上是不够的.
- 像Joseph M. Juran这样的先驱者和像Six Sigma这样的概念为先进的质量策略奠定了基础.
研究的目的:
- 突出采用新型质量管理技术对长期业务成功的重要性.
- 介绍和解释Quality by Design (QbD) 作为现代质量范式的基本原则.
- 强调QbD在通过积极的风险管理和流程控制来确保产品质量的作用.
主要方法:
- 讨论设计质量 (QbD) 的核心原则.
- 解释QbD原则在产品开发和制造过程中的整合.
- 详细介绍QbD关键组件:质量目标产品配置文件 (QTPP) 和关键质量属性 (CQA).
主要成果:
- 通过专注于风险管理和产品属性,QbD提供了一种系统的质量保证方法.
- 实施QbD确保产品始终符合预先确定的质量标准.
- QbD使制造商能够实现灵活性,同时保持严格的质量合规性.
结论:
- 设计质量 (QbD) 代表了工业质量管理的重大范式转变.
- 对于那些旨在实现长期成功和市场领导地位的公司来说,采用QbD是必不可少的.
- 通过积极主动,以科学为基础的方法,QbD促进了高质量的产品的创造.
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