| 王晓娟,曹琰,马锐,徐莉,郭中平.浅析世卫组织《良好的药典质量规范》及对我国药典实践的意义[J].中国药事,2017,(10):1158-1164 |
| 浅析世卫组织《良好的药典质量规范》及对我国药典实践的意义 |
| Discussion on WHO GPhP and the Significance to the Practice of Chinese Pharmacopoeia |
| 投稿时间：2016-11-28 |
| DOI：10.16153/j.1002-7777.2017.10.011 |
| 中文关键词: 世界卫生组织 药品标准 药典 良好的药典质量管理规范 药典协调 |
| 英文关键词: world health organization (WHO) pharmaceutical standards pharmacopoeia Good Pharmacopoeia Practices (GPhP) pharmacopoeial harmonization |
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| 中文摘要: |
| 随着药典在药品监管和其他相关领域中发挥的作用日趋显著，药典的质量管理规范也越发显现其重要性。在此背景下，WHO出台《良好的药典质量规范》（Good Pharmacopoeia Practices，GPhP）具有其特殊的现实意义。本文以WHO GPhP最新内容为基础，结合《中国药典》的具体实践进行初步分析和解读。 |
| 英文摘要: |
| Pharmacopoeia plays a more and more important role in drug administration and other related areas. Good Pharmacopoeia Practices (GPhP) also increasingly shows its importance. Under the circumstance, GPhP issued by WHO represents special practical significance. This paper made a preliminary analysis and interpretation of the latest contents of WHO GPhP combined with the practical experience of the Chinese Pharmacopoeia. |
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