EDQM对于变更的分类

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工艺的微小变更
Change in batch size of final substance or intermediate up to 10-fold compared
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to the original batch size 原料药或中间体的批量的改变，与原批量相比改变
了 10 倍
Change in batch size of final substance or intermediate: downscaling up to 10-
在提交变更申请时，以下几个表格是必填的。
在准备变更资料时，要参照指南文件PA/PH/CEP (04) 2, 6R，因为它有更进一步的论述。
Notifications 通知类的变更
Immediate
Change in the name and/or address of the certificate holder of the final substance*证书持有人的名称和/或地址的变更 Change in the name and/or address of the manufacturing site or quality control site for the final substance*生产或 QC 之处的名称和/或地址的变更 Deletion of a manufacturer of intermediate or of a manufacturing or quality control testing site for the final substance 删除某个中间体的一个生产商，或 者删除原料药的一个生产地址，或者删除原料药的一个 QC 检验地址 Change in the name and/or address of a manufacturer of an intermediate used in the manufacture of the final substance*某个中间体生产商的名称和/或地址改 变
重要的质量标准参数；起始物料/中间体/试剂，删除一个检验方法
Minor changes to a test procedure for a starting material/intermediate/reagent
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used in the manufacturing process of the final substance 起始物料/中间体/试
起始物料/中间体/试n the specification parameters and/or limits of the immediate
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packaging of the final substance 内包材的质量标准参数和/或限度的改变
Change in the specification of the secondary packaging 外包材质量标准的改
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变
Submission of a revised CEP for a starting material, when the manufacturing
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sites mentioned on this CEP are unchanged 不适用，不必关心
* updated declarations according to the relevant annexes are to be submitted
Change in the name and/or address of a manufacturer of a starting material used
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in the manufacture of the final substance 起始物料生产商的名称和/地址的改
变
Deletion of a manufacturer or a quality control site for a starting material used
Change or addition of a manufacturer of a starting material or intermediate used in the manufacturing process of the final substance when the proposed manufacturer is part of the same group as the currently approved manufacturer 不适用，不必关心
Minor changes to a test procedure for the final substance. Editorial changes to a method description annexed to a certificate of suitability 原料药检验方法的微 小改变。CEP 证书附件中的检验方法的描述之编辑性修改 Addition of a specification parameter for the final substance 原料药增加一个 质量标准项目
剂，对一个检验方法的微小改变
Tightening of the specification limits for a starting material/
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intermediate/reagent used in the manufacturing process of the final substance
Change or addition of a manufacturing site/workshop for the final substance when the proposed manufacturer is part of the same group as the currently approved manufacturer*改变或者新增了原料药的生产工厂/车间，而且新 的生产商与现有生产商属于同一集团
Introduction of a new CEP to describe a starting material used in the
Annual
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Implementation date (annual notifications)
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Deletion of a non-significant specification parameter for the final
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substance/starting material/intermediate or deletion of a test procedure for a
starting material/intermediate/reagent 原料药/起始物料/中间体，删除一个不
Changes to quality control testing for an intermediate or for the final substance 中间体或者原料药的质量控制检验项目的改变
Introduction of a new site of micronisation*新增一个地址，用于微粉化 Tightening of the specification limits for the final substance 原料药质量标准 限度的收紧
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in the manufacture of the final substance 起始物料的生产商或者质量控制地
址的删除
Change in the code product/reference number and/or in the brand name of the
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final substance or any material used in its manufacture 原料药或所用物料的代
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fold 原料药或中间体的批量的改变，与原批量相比改变不到 10 倍
Addition of a new in-process test and limit applied during the manufacture of
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the final substance 原料药生产过程中引入新的中间过程检验项目和限度
码、索引号和/或商标的改变
Changes to quality control testing for a starting material 起始物料的质量控制
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检验项目的改变
Minor change in the manufacturing process of the final substance 原料药生产
Notifications 通知类的变更
Immediate
manufacturing process of a final substance 不适用，不必关心
Introduction of a revised CEP for a starting material when the manufacturing sites mentioned on this CEP are changed 不适用，不必关心 Deletion of a CEP for a starting material 不适用，不必关心
Change to an approved stability protocol 改变已批准的稳定性试验方案 Deletion of an approved change management protocol related to the final substance 取消已批准的有关原料药的“变更管理方案” Implementation of changes foreseen in an approved change management protocol that does not require further supportive data 已批准的“变更管理方 案”（不需要进一步的支持性数据）中已经预见到的变更的执行
Change in the composition of the immediate packaging 内包材的材质改变 Change in the composition of the secondary packaging 外包材的材质改变
Removal/reduction of the re-test period from the Certificate of suitability / change to more restrictive storage conditions 取消或缩短 CEP 证书所列之复 测期，储存条件趋于更严格
Deletion of a non-significant in-process test applied during the manufacture of
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the final substance 原料药生产过程中，删除一个不重要的中间过程检验项
目
Tightening of the limits of in-process tests applied during the manufacture of
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the final substance 原料药生产过程中，收紧某个中间过程检验项目的限度
Addition of a specification parameter for a starting
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material/intermediate/reagent 起始物料/中间体/试剂，新增一个质量标准参
数
EDQM对于变更的分类
备注，如果某个变更在下面几个表格中都没有提到，则视为微小变更。依据是指南文件PA/PH/CEP (04) 2, 6R第3页的一句话，如下：Any change not classified as a notification or a major change should be classified as a minor change.