印度药典参考标准:监管药品质量的关键工具
Arvind Kumar Sharma1, Shruti Rastogi2, Priyanka Nagar2
1Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Sector- 23 Raj Nagar, Ghaziabad, Uttar Pradesh, 201002, India. arvind.ipc@gov.in.
Therapeutic innovation & regulatory science
|January 28, 2026
概括
药典参考标准确保药品的质量和安全. 这篇文章详细介绍了他们的发展,重点是印度药典参考标准,以填补利益相关者的知识空白.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 监管事务 监管事务
背景情况:
- 药典参考标准对于药品质量,纯度和一致性至关重要.
- 官方机构制定这些标准,指导全球的分析和质量控制方法.
- 现有的文献不充分记录了发展过程,造成了知识差距.
研究的目的:
- 详细说明制定药典参考标准的科学和监管过程.
- 为研究人员,监管机构和行业利益相关者解决知识差距.
- 强调印度药典参考标准的发展及其在全球制药协调中的作用.
主要方法:
- 根据ISO 17034,ISO指南31,ISO指南34,ISO/指南35:2017和WHO TRS 943.3的原则进行绘制.
- 详细介绍了制药典参考标准开发的关键阶段.
- 专注于印度药典参考标准的具体背景.
主要成果:
- 药典参考标准开发阶段的全面文档.
- 强调印度药典参考标准在分析测试和质量控制中的关键作用.
- 说明遵守这些标准如何确保药物的安全性和有效性.
结论:
- 严格的开发和遵守药典参考标准对于药品质量至关重要.
- 这篇文章为了解参考标准的开发提供了宝贵的资源,特别是对于印度药典.
- 确保药品质量的一致性保护公共健康,并保持对药物的信心.
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