How can a CEP for a starting material be used in a CEP application for an API?

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如果提交的适用性（CEP），用于向EDQM的活性物质的证书的应用程序时，卷宗具有包含活性物质的质量的大量信息，其合成，以及对所使用的起始原料和中间体。该文件提供的规格为这个目的，可以追溯到2007年，题为“卷宗的内容进行化学纯度和微生物质量”（PA / PH/ CEP（04）1，4R）。）报告说，在章“控制材料（3.2.S.2.3）”：
“以合成由一个或少数几个步骤的一个线路的情况下，起始物（S）的制造中的全部细节，应给予和/或至少详细规格特别是关于杂质分布包括残留溶剂和催化剂或者，用于启动在适宜的欧洲药典的证书中描述的材料可以被提供，如果有的话。“
所以CEP证书为原料，可用于申请一个API CEP其中省去了原料中这样的应用程序的详细说明。但什么是确切的条件和这样的程序要求？题为“使用CEP证书来形容有关申请CEP另一个在原料”（PA / PH/ CEP（14）06）新EDQM的文档提供了一些信息。根据该文献，可以使用下面的条件下，在应用过程中的起始原料的CEP：
原料必须包括的CEP应用的活性成分。
在CEP为原料必须已被授予和有效的。
在CEP对原料的副本须随同申请的活性成分的CEP。
必须应用 - 因为它们是在CEP中指定的 - 作为活性成分的原料的规格齐全的生产中的API的CEP申请中描述。
下列有关材料或CEP的生命周期进一步条文要注意：
有效成分的CEP具有紧随CEP对原料的任何变动或更新后修改为好。这通常是因为每年通知的一部分。例外情况是：在原材料的规格变化（一个次要版本在默认情况下，必须提交）或生产现场不改变原料的规格变化（需即时通知）。
若在CEP为原料被暂时或永久中止或如果其有效期期满时，活性成分的CEP，必须相应地更新：对原料的无效CEP的所有引用都被删除，而是引用一个从另一个源原料CEP必须要添加。如果原料的替代来源没有CEP，其质量需要充分相应说明。
在一般的详细信息，必须提供关于涉及在制造过程中的原料的生产厂。
If you submit an application for a certificate of suitability (CEP) for an active substance to the EDQM, your dossier has to comprise extensive information on the quality of the active substance, its synthesis as well as on the used starting materials and intermediates. The document providing the specifications for this purpose, dates back to the year 2007 and is titled "content of the dossier for chemical purity and microbiological quality" (PA/PH/CEP (04) 1, 4R).) It says in the chapter "control of materials (3.2.S.2.3)":
"In the case of a route of synthesis consisting of one or only a few steps, full details of the manufacture of the starting material(s) should be given and/or at least detailed specifications especially regarding the impurity profile including residual solvents and catalysts. Alternatively, for starting materials described in the European Pharmacopoeia certificates of suitability can be provided, if available."
So CEPs for raw materials can be used to apply for an API CEP which eliminates the need for the detailed description of the starting material in such an application. But what are the exact conditions and requirements for such a procedure? A new EDQM document entitled "Use of a CEP to describe a starting material in on application for another CEP" (PA/PH/CEP (14) 06) provides some information. According to this document it is possible to use a starting material CEP in the application process under the following conditions:
The raw material must be covered by the CEP application for the active ingredient.
The CEP for the raw material must already be granted and valid.
A copy of the CEP for the raw material must accompany the application for the active ingredient CEP.
As described in the API CEP application for the manufacture of the active ingredient the complete specifications of the raw material - as they are specified in the CEP - have to be applied.
Following further provisions in relation to the life cycle of the material or its CEP have to be noted:
Immediately after any change or update of the CEP for the raw material the active ingredient CEP has to be revised as well. This is usually done as part of the annual notification. Exceptions are: a change in the specifications of the raw material (a minor revision by default has to be submitted) or a change of the production site without changing the specifications of the raw material (an immediate notification is required).
If the CEP for the raw material is suspended temporarily or permanently or if its validity period has expired, the active ingredient CEP has to be updated accordingly: all references to the invalid CEP of the raw material have to be removed, and instead references to a raw material CEP from another source have to be added. If the raw material from the alternative source has no CEP, its quality needs to be fully described accordingly.
In general detailed information has to be provided about all production sites involved in the manufacturing process for the raw material.

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