监管实施光学一致性断层扫描作为药品填充剂中的分析技术
Jesús Alberto Afonso Urich1,2, Raymar Andreina Lara Garcia2, Matthias Wolfgang2
1Institute of Process and Particle Engineering, Graz University of Technology, Graz, Austria.
Frontiers in medicine
|January 23, 2026
概括
光学一致性断层扫描 (OCT) 为药物配方提供高分辨率成像. 需要标准化和监管指导方针,以便在药品质量控制中更广泛地采用.
科学领域:
- 制药技术 制药技术 制药技术
- 非破坏性的成像成像.
- 质量控制 质量控制 质量控制
背景情况:
- 光学一致性断层扫描 (OCT) 为药物配方提供高分辨率,非破坏性成像.
- 目前的局限性包括缺乏药典专著和具体的监管指南,这阻碍了广泛接受.
- 越来越多的监管强调先进的分析,方法验证,设计质量 (QbD) 和良好制造实践 (GMP) 正在增加对OCT的兴趣.
研究的目的:
- 为制药行业的海外和海外国家的发展,实施和监管评估提供综合的视角.
- 审查OCT在药物应用中的实际考虑和不断变化的监管框架.
- 突出需要标准化和将OCT方法纳入监管框架的需要.
主要方法:
- 审查当前的文献和监管趋势,涉及到药品质量控制的OCT.
- 对实施过程的分析和采用海外技术的实际挑战.
- 检查不断变化的监管环境和行业利益相关者的参与.
主要成果:
- 海洋和海上国家/地区是评估药物配方质量的宝贵工具,包括涂层均性和多层结构.
- 监管机构对先进的分析技术越来越感兴趣,比如海外国家和地区.
- 由于需要加强质量控制和遵守QbD和GMP,行业采用正在进展.
结论:
- 海外国家和地区有很大的潜力成为现代药品质量控制战略的组成部分.
- 行业,监管机构和标准制定组织之间的持续合作对于标准化和监管纳入至关重要.
- 解决目前的指导方针和专著的缺口将有助于在制药制造业中更广泛地实施OCT.
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