关于温度循环研究的行业观点,以满足监管温度探险支持要求:调查结果和建议
Claudia Arana1, Junyan Ji2, Elisabeth Krug3
1Bristol Myers Squibb, New Brunswick, NJ, USA.
Journal of pharmaceutical sciences
|September 29, 2023
概括
温度循环稳定性研究可以确保药物产品在航运期间的质量. 一项行业调查揭示了共同的最佳实践,以满足超越ICH指南的全球监管要求.
科学领域:
- 制药科学 制药科学
- 药物产品的稳定性 药物产品的稳定性
- 监管科学 监管科学
背景情况:
- 运输和患者使用期间的温度偏差可能会影响药物产品的质量,有效性和安全性.
- 澳大利亚和巴西等国家的法规要求稳定性研究支持真实世界的温度探险.
- 现有的ICH指南 (Q1A(R2),Q5C) 可能无法完全解决这些国家特定要求.
研究的目的:
- 对温度循环稳定性研究的行业实践进行调查.
- 确定常见和最佳实践,以满足全球监管对温度外游期间药物产品稳定性的期望.
- 为设计研究提供框架,以满足澳大利亚,巴西和其他地区的营销许可要求.
主要方法:
- 在国际创新和质量联盟 (iqconsortium.org) 成员公司中进行的跨行业调查.
- 分析调查答案,以了解当前对温度循环稳定性研究的解释和方法.
- 根据调查结果确定常见和最佳实践.
主要成果:
- 没有一种方法适合所有温度循环稳定性研究.
- 存在共同和最佳实践,可以满足全球监管准则.
- 行业实践各不相同,突出了对标准化方法的需要.
结论:
- 温度循环稳定性研究对于在短期温度外游期间确保药物产品质量至关重要.
- 采用常见和最佳实践可以帮助公司满足各种全球监管要求.
- 进一步协调温度循环稳定性研究的方法对制药行业有利.
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