QP声明：修订后的问答

QP Declaration: Revised Questions and Answers

QP声明：修订后的问答

The Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMDh) of the Heads of Medicines Agencies has revised its Question and Answers Document on the QP Declaration.

互认协作组和HMA非集中程序已修订了其关于QP声明的问答文件。

The guidance has been updated to explain the types of QP declarations that must be submitted to support individual changes to marketing authorisation: "Which Qualified Person declaration(s) are required in support of individual types of changes to a Marketing Authorisation, to confirm that the active substance is manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials?"

指南已进行了更新，解释了必须提交来支持上市许可单个变更的QP声明的类型：“为了支持上市许可不同变更类型需要哪些QP声明，以确活性物质生产负责详细的起始物料GMP指南？”

The answer is given for the different possible changes: API manufacturer, finished product manufacturer and batch release site.

文件中对不同可能的变更给出了答复：API生产商、制剂生产商和批放行场所。

New active substance manufacturer or new site of an already approved site: "QP declarations should be provided from each of the registered finished product manufacturing and batch release sites located in the EU/EEA. The declarations should cover all new intermediate and API manufacturers…".

新活性物质生产商或已批准场所的新场所：“QP声明应由位于EU/EEA的每个注册的制剂生产和批放行场所提交。声明应覆盖所有新的中间体和原料药生产商……”。

New finished product manufacturer:  "as a minimum QP declarations should be provided from the proposed new finished product manufacturer (if located within EU/EEA), as well as at least one of the registered EU/EEA batch release sites." (…)  "A further declaration from the QP responsible for batch certification is expected when the batch release site is a different site from the site which is added with the proposed variation."

新的制剂生产商：“最低要求，QP声明应由所拟新制剂生产商提供（如果位于EU/EEA境内），至少有一个注册过的EU/EEA批放行场所。”……“如果批放行场所不同于增加在所拟变更中的场所时，要求负责批认证的QP再出具一份声明”。

New finished product manufacturer which is also responsible for batch release or simultaneous addition of a new finished product manufacturer and a new batch release site: "as a minimum QP declarations should be provided from the new batch release site, as well as the proposed new finished product manufacturer (when located within EU/EEA, if different from the former)."

新的制剂生产商，其也负责批放行或同步增加新制剂生产商和新批次放行场所：“最低要求，QP声明应由新批次放行场所提供，和所拟的新制剂生产商（如果位于EU/EEA境内，并且不同于前者）”。

New batch release site: "a QP declaration should be provided from the proposed new batch release site, covering all registered drug substance manufacturing sites (main and intermediate manufacturing sites)."

新批准放行场所：“一份QP声明应由提议新批次放行场所提供，覆盖所有注册的药品生产场所（主要生产场所和中间体生产场所）。”

In the text, also the following question is answered: Is it acceptable to provide a single declaration signed by one QP (rather than multiple declarations)?

在文中，还回答了下面的问题：是否可以接受提供交一份由一个QP签字的单独声明（而不是多份声明）？

The answer is that this "may be acceptable" if this declaration will be "signed on behalf of all the involved QPs" and supported by a "technical agreement as described in Chapter 7 of the GMP Guide and the QP providing the declaration is the one identified in the agreement as taking specific responsibility for the GMP compliance of the active substance manufacturer(s)."

回答是这“可以接受”，前提是该声明“由代表所有涉及QP的人签名”，并且具备“EU GMP指南第7章所述的技术协议，在声明上签字的QP在协议中指定来承担指定的活性物质生产商GMP符合性的职责”。

The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. The revised document CMDh/340/2015, Rev.2 can be found in CMDh Question & Answers.

HMA是成员国药监局的领导网络，该组织负责EEA境内所用人药和兽药法规。修订后的文件CMDh/340/2015第2版可以在上述网址找到。

来源：julia

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