数字参考材料:生物/制药制造业质量和合规性的新标准
1Calibr-Skaggs Institute for Innovative Medicines, 11119 N Torrey Pines Rd, La Jolla, CA 92037.
PDA journal of pharmaceutical science and technology
|August 20, 2025
概括
数字参考材料 (dRMs) 对于现代生物制药制造至关重要,改善数据完整性和自动化质量控制. 实施DRM通过数字基础设施和协作来支持监管合规和智能制造.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 数据科学数据科学数据科学
- 监管科学 监管科学
背景情况:
- 生物制药行业正在经历数字化,增加对结构化,互操作性和合规数据的需求.
- 数字参考材料 (dRM) 是物理参考标准的机器可读版本,对于数据完整性和自动化质量控制至关重要.
- 药品监管机制提高了制药制造业的监管透明度.
研究的目的:
- 定义,结构,并探索dRMs在制药行业的实施.
- 检查有关监管倡议和dRM的商业应用.
- 讨论DRM的技术基础和整合挑战.
主要方法:
- 审查监管举措 (例如,FDA的eCTD 4.0,KASA) 和药典数字化.
- 对技术标准 (XML,JSON,AnIML) 和实验室系统集成 (LIMS,ELN,CDS) 的分析.
- 对染色体实施挑战的案例研究考虑.
主要成果:
- 对于数据完整性,自动化质量控制和监管合规性来说,DRM是必不可少的.
- 各种技术格式和实验室系统可以支持dRM集成.
- 在标准化dRM方面存在挑战,特别是在染色学中,因为方法的变化.
结论:
- dRM是智能制造的关键推动者,支持人工智能,数字双胞胎和全球质量系统.
- 投资于数字基础设施,标准和协作是战略上的必需品.
- 实现DRM的全部潜力需要利益相关者的承诺和数字能力的进步.
关键词:
动物 动物生物制药制造业 生物制药制造业染色学方法验证的验证方法数字参考材料 (dRM) 是指数字参考材料.数字双胞胎是一个数字双胞胎.美国食品和药物管理局 K FDA K FDA我们的LIMS LIMS实验室信息学 实验室信息学质量控制 (QC) 是指质量控制.监管合规性 监管合规性结构化数据是结构化数据.美国标准 数字标准 USP 数字标准在eCTD 4.0中,更多相关视频
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