EDQM对于变更的分类

更新时间:2023-07-12 04:37:34 阅读: 评论:0

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, 6R3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.
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。
一百英语怎么写
Notifications通知类的变更
Immediate
Annual
Implementation date (annual notifications)
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 ud in the manufacture of the final substance*某个中间体生产商的名称和/或地址改变
-
-
Change or addition of a manufacturer of a starting material or intermediate ud in the manufacturing process of the final substance when the propod manufacturer is part of the same group as the currently approved manufacturer不适用,不必关心
-
-
Change or addition of a manufacturing site/workshop for the final substance when the propod 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
-
-
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
-
-
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
-
-
Change in the composition of the immediate packaging内包材的材质改变
-
-
Change in the composition of the condary 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
-
-
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 foreen 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
-
-
Introduction of a new CEP to describe a starting material ud in the manufacturing process of a final substance不适用,不必关心
-
-
Introduction of a revid CEP for a starting material when the manufacturing sites mentioned on this CEP are changed不适用,不必关心
-
-
李宁官方网店Deletion of a CEP for a starting material 不适用,不必关心
-
-
Change in the name and/or address of a manufacturer of a starting material ud 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 ud 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 final substance or any material ud in its manufacture原料药或所用物料的代码、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检验项目的改变
-
Minor change in the manufacturing process of the final substance原料药生产工艺的微小变更
-
Change in batch size of final substance or intermediate up to 10-fold compared 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
-
Change in batch size of final substance or intermediate: downscaling up to 10-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
-
Addition of a new in-process test and limit applied during the manufacture of 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
-
Deletion of a non-significant in-process test applied during the manufacture of 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 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 material/intermediate/reagent起始物料/中间体/试剂,新增一个质量标准参数
-
Deletion of a non-significant specification parameter for the final 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 ud in the manufacturing process of the final substance起始物料/中间体/试剂,对一个检验方法的微小改变
-
Tightening of the specification limits for a starting material/ intermediate/reagent ud in the manufacturing process of the final substance起始物料/中间体/试剂的质量标准限度的收紧
-
Change in the specification parameters and/or limits of the immediate 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 condary packaging外包材质量标准的改变
-
Submission of a revid CEP for a starting material, when the manufacturing 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
堤莎也加
Notifications for TSE certificates不适用,不必关心
Immediate
Annual
Implementation date
Deletion of a source country or deletion of a tissue ud in the preparation of the final product
-
-
Change or addition of a manufacturing site for the final substance when the propod manufacturer is part of the same group as the approved manufacturer*
-
-
Change in the quality assurance system applied in the manufacturing site*
-
-
Minor change in the specification of the final substance
-
-
Minor change in the manufacturing process (including process parameters) of the final substance
-
* updated declarations according to the relevant annexes are to be submitted
Minor changes微小表更
Change or addition of a manufacturer of a starting material ud in the manufacturing process of the final substance改变或者增加一个起始物料生产商
Change or addition of a manufacturer of an intermediate ud in the manufacturing process of the final substance*改变或者增加一个中间体生产商
Change or addition of a manufacturer of a starting material ud in the manufacturing process of a biological substance不适用,不必关心 
Change or addition of a manufacturer of an intermediate ud in the manufacturing process of a biological substance*不适用,不必关心 
Change or addition of a manufacturing site/workshop for the final substance*改变或增加一个原料药的生产厂/白色污染图片车间
Change or addition of a manufacturer for a biological substance*不适用,不必关心 
Addition of an alternative sterilisation site for the final substance*不适用,不必关心 
Minor changes to the manufacturing process of a biological substance不适用,不必关心 
For a “double” Certificate of suitability (for chemical purity and microbiological quality and for TSE risk), change in source of a material ud in the preparation of the final substance from a TSE risk material to a vegetable, synthetic, or non-TSE risk material不适用,不必关心 
Change in batch size of final substance or an intermediate more than 10-fold compared to the original batch size原料药或者中间体的新批量与原批量相比,改变程度大过了10倍。
Change in batch size of a biological substance不适用,不必关心 钱的词语
Widening of approved specification limits for the final substance to be in line with the limits of the Ph. Eur monograph/ICH/VICH guidelines为了与欧洲药典专论或者ICH/VICH指南所规定的限度相符,而放宽已批准的原料药的质量标准限度
Minor changes to the manufacturing process of a biological substance, including change in batch size不适用,不必关心
Changes to a test procedure (including replacement or addition) for the biological substance/starting material/intermediate or changes to a biological method不适用,不必关心 
Extension/addition of the re-test period of the final substance and/or change in the storage conditions for the final substance延长或引入原料药的复测期,和/或改变原料药的储存条件
Propod retest period (in months)拟采用的复测期(按月数)
Commercial packaging市售包装
Recommended storage conditions建议储存条件
Minor changes to an approved change management protocol that do not change the strategy defined in the protocol对已批准的“变更管理方案”做微小变更,而且不改变原方案中的策略
Implementation of changes foreen in an approved change management protocol that requires further supportive data已批准的“变更管理方案”(需要进一步的支持性数据)中已经预见到的变更的执行
Introduction of a new CEP for a starting material, when the specifications of the starting material are changed不适用,不必关心
Submission of a revid CEP for a starting material, when the specifications mentioned on this CEP are changed不适用,不必关心
Other minor changes (by default)其他微小变更(默认)
Describe briefly any non-listed minor changes in this box :在此框中简述表中未列之任何微小变更
* updated declarations according to the relevant annexes are to be submitted
Major changes重大变更
Change/addition of the manufacturer of a starting material or intermediate, when the propod manufacturer us a substantially different route of synthesis or manufacturing conditions, which are likely to change the qualitative and/or quantitative impurity profile (eg. new reagents, solvents, materials are introduced in the synthesis)*改变/增加一个起始物料或者中间体的生产商,而且新生产商采用明显不同的合成路线或者生产条件,有可能改变(原料药的)杂质定性和/或定量特征(例如合成中采用了新试剂,溶剂,物料)
Change in the manufacturing process of the final substance that regards the sterilization step(s), including changes in batch size of a sterile substance不适用,不必关心
Substantial change to the manufacturing process/addition of an alternative manufacturing process for a starting material, intermediate or final substance likely to change the qualitative and/or quantitative impurity profile (eg. new reagents, solvents, materials are introduced in the synthesis)起始物料、中间体或者原料药的生产工艺明显改线,或者增加一个替代的生产工艺,有可能改变(原料药的)杂质定性和/或定量特征(例如合成中采用了新试剂,溶剂,物料)
Changes in the manufacturing process of a herbal substance related to geographical source or production不适用,不必关心 
rhd血型阳性是什么意思
Widening or deletion of approved in-process test limits, which may have a significant effect on the overall quality of the final substance放宽或者删除中间过程检验限度,可能对原料药的总体质量产生较大影响
Widening of the approved specification limits for the final substance放宽原料药已批准的质量标准限度
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Widening of the approved specification limits for starting materials/ intermediates, which may have a significant effect on the overall quality of the final substance放宽起始物料已批准的质量标准限度,可能对原料药的总体质量产生较大影响
Deletion of a specification parameter which may have a significant effect on the overall quality of the final substance删除某个质量标准参数,可能对原料药的总体质量产生较大影响
Change in the composition of immediate packaging for a sterile substance不适用,不必关心 
Introduction of a new design space or extension of an approved design space or of a post approval change management protocol related to the final substance针对原料药,引入一个新的“设计空间”或者扩展一个已批准的“设计空间”,或者引入一个批准CEP后的“变更管理方案”
Introduction of a post approval change management protocol related to the final substance针对原料药,引入一个批准CEP后的“变更管理方案”
Major changes to an approved change management protocol对已批准的“变更管理方案”的重大改变
Deletion of a CEP for a starting material and replacement by another source that does not have a CEP不适用,不必关心 
Major changes for TSE certificates不适用,不必关心
Change/addition of a source country or tissues for TSE risk material
Change/addition of a manufacturer of a starting material or intermediate*
Change/addition of a manufacturing site where other TSE materials than the substance are procesd*
Substantial changes in the manufacturing process that are likely to affect the TSE risk
防止网络诈骗
* for a manufacturer of intermediate or the final substance, updated declarations according to the relevant annexes are to be submitted

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