控制制药制造中的清洁剂残留物:一个协调的科学战略
Regulatory toxicology and pharmacology : RTP
|June 12, 2023
概括
本研究提出了一项协调的策略,用于控制制药制造中的清洁剂成分 (CAI) 残留物. 最坏情况计算和新的毒理学评估框架确保残留物处于安全水平.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 毒理学 毒理学 毒理学
- 化学安全 化学安全
背景情况:
- 在制药生产中控制清洁剂成分 (CAI) 的残留物对于患者安全至关重要.
- 评估CAI残留物的现有方法可能很复杂,缺乏协调.
- 通常使用标准清洁限值 (SCL),但它们对所有CAI的充分性需要进一步验证.
研究的目的:
- 为制药制造业中控制CAI残留物提出一个科学合理和协调的战略.
- 为低关注度的CAI验证最坏情况下的清洁验证计算的充分性.
- 开发和验证一种新的协调战略,用于对CAI残留物的毒理学评估.
主要方法:
- 使用GMP SCLs进行最坏情况清洁验证计算的演示.
- 制定对CAI残留物进行协调的毒理学评估框架.
- 基于危险和暴露因素以及关键影响等级的框架的验证.
主要成果:
- 使用GMP SCL进行最坏情况下的计算足以控制低关注的CAI残留物.
- 一个新的,协调的框架用于对CAI残留物的毒理学评估已经开发和验证.
- 该框架将各种CAI纳入其中,包括那些具有未知的关键影响的CAI,并将其分为六组.
结论:
- 拟议的战略提供了一个科学合理和协调的方法来管理CAI残留物.
- 经过验证的框架简化了清洁剂混合物的毒理学评估.
- 这种方法通过有效控制CAI残留物来确保药品的安全性.
关键词:
CA 清洁剂 清洁剂 清洁剂清洁剂的成分 清洁剂的成分交叉污染是一种交叉污染.曝光的理由 曝光的理由行动方式 推理 行动方式允许的每日PDE暴露时间阅读横向的阅读.剩余物 剩余物 剩余物SCL 标准的清洁限值值更多相关视频
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