| 周萌萌,江凡,黄莺.药品稳定性研究相关要求及常见缺陷分析[J].中国药事,2023,(11):1282-1289 |
| 药品稳定性研究相关要求及常见缺陷分析 |
| Relevant Requirements and Common Defect Analysis for Stability Research of Drug |
| 投稿时间：2023-06-21 |
| DOI：10.16153/j.1002-7777.2023.11.008 |
| 中文关键词: 稳定性试验 药品检查 缺陷分析 异常事件 委托研究 |
| 英文关键词: stability testing drug inspection defect analysis adverse events commissioned research |
| 基金项目: |
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| 中文摘要: |
| 目的：探讨药品稳定性研究的要求及常见缺陷，旨在为稳定性研究提供参考和借鉴。方法：梳理国内外相关法律法规和指导原则对药品稳定性研究的要求，统计检查过程中常见的稳定性相关缺陷，探索稳定性研究需考虑和关注的内容。结果与结论：企业可根据法律法规和相关指导原则对药品稳定性研究的要求，参考现场检查中常见的例如稳定性试验规程/方案的制定与执行、数据可靠性、稳定性试验设备或设施、检查记录等方面的缺陷，结合质量管理体系架构，综合考虑品种特性，制定适宜的方案，不断提升稳定性研究相关工作的质量和水平。 |
| 英文摘要: |
| Objective: To explore the requirements and common defects in drug stability research, providing references and guidance for stability research. Methods: The requirements for drug stability research in relevant domestic and international regulations and guidelines were sorted out, common stability-related defects in the process of inspections were collected, and the considerations and focal points in stability research were explored. Results and Conclusion: Enterprises could according to the requirements of laws, regulations, and relevant guidelines for drug stability research, refer to the common defects mentioned in field inspection, such as the formulation and implementation of stability test procedures/programs, data integrity, the equipment or establishment for stability test, and inspection record, etc. By integrating the framework of quality management systems and the characteristics of the drug products, appropriate strategies can be developed to continuously improve the quality and level of stability research related work. |
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