| 药品生产工艺参数验证的研究 |
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| 引用本文： | 梁毅.药品生产工艺参数验证的研究[J].中国药房,2010(41):3843-3845. |
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| 作者姓名： | 梁毅 |
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| 作者单位： | 中国药科大学国际医药商学院,南京市210009 |
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| 摘 要： | 目的:促进药品生产工艺参数验证水平的提高。方法:对药品生产工艺参数验证存在的误区进行分析,提出验证过程中参数限度的概念与技术处理手段,探讨工艺参数验证的具体操作方法。结果与结论:工艺参数验证主要包括工艺参数确定的合理性、验证研究及3个参数限度的设置,是工艺验证和工艺规程制定的基础,直接关系到药品生产质量,必须进行完善。
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| 关 键 词： | 工艺 验证 参数 药品生产质量管理规范 |
Study of the Validation for Process Parameters |
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| LIANG Yi.Study of the Validation for Process Parameters[J].China Pharmacy,2010(41):3843-3845. |
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| Authors: | LIANG Yi |
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| Institution: | LIANG Yi(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 210009,China) |
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| Abstract: | OBJECTIVE：To promote the validation for pharmaceutical process parameters.METHODS：The mistakes of the validation for pharmaceutical process were analyzed.The concept of the parameter limit and the technical disposal in the process of validation were put forward.The specific operating method of process parameters validation was investigated.RESULTS CONCLUSIONS：Process parameters validation includes the reasonability of confirming process parameters,validation research and setting parameter limit.It is the foundation of the process validation and regulation,which are associated with the quality of drugs.Process parameters validation should be improved. |
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| Keywords: | Process Validation Parameters GMP |
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