| 引用本文: | 许静玉,唐谦,钱璟,石蔚华,胡涛,高建青.化学药品口服固体制剂生产场地变更的技术风险考量[J].中国现代应用药学,2022,39(5):690-694. |
| XU Jingyu,TANG Qian,QIAN Jing,SHI Weihua,HU Tao,GAO Jianqing.Technical Risk Considerations of Manufacturing Site Changes of Chemical Solid Oral Dosage[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(5):690-694. |
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| 摘要: |
| 药品生产场地变更可能会关联药品处方、原辅料供应商、生产工艺、工艺参数和批量等其他注册管理事项的变更，是所有变更情形中最复杂的。本文探讨化学药品口服固体制剂生产场地变更的技术风险考量点，结合技术审评中的部分案例，阐述了关键质量属性与关键工艺参数或关键控制指标等影响因素的关系，以期为药品生产企业变更生产场地时如何开展研究提供借鉴和启示。 |
| 关键词: 生产场地变更 关键质量属性 关键工艺参数 案例 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.05.021 |
| 分类号:R954 |
| 基金项目: |
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| Technical Risk Considerations of Manufacturing Site Changes of Chemical Solid Oral Dosage |
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XU Jingyu1,2,3, TANG Qian2,3, QIAN Jing2,3, SHI Weihua2,3, HU Tao2,3, GAO Jianqing1
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1.College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310030, China;2.Zhejiang Center for Drug &3.Cosmetic Evaluation, Hangzhou 310012, China
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| Abstract: |
| Drug manufacturing site change is the most complicated situation which may combine with changes of formulation, supplier of active pharmaceutical ingredients and excipients, manufacturing process, process parameters, batch, and other registration administration matters. The article discussed the technical risk considerations of chemical solid oral dosage of manufacturing site changes and described the relationship between critical quality attributes and critical process parameters or key control indicators according to specific examples, which in order to provide reference and inspiration for how to carry out research when pharmaceutical manufacturers change their production sites. |
| Key words: manufacturing site change critical quality attributes critical process parameters specific example |
