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 | - | - | 一百英语怎么写|
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倍 | - | ||
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倍 | - | ||
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 | - | ||
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* | 堤莎也加 | - | - | |||
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 | ||||||
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 | ||||||
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