欧洲QP协会问答：如何成为QP

                                欧洲QP协会问答：如何成为QP  

2014-10-09 09:34:42|  分类： 欧盟知识|

European Qualified Person Association - Publications/Question and Answer Documents

欧洲QP协会—出版物/问答文件

How to become a Qualified Person 如何成为QP

Q: I am a Chemist. How can I become a QP?
问：我是一个化学师，我怎样才能成为一个QP呢？

A: In Article 49 of Directive 2001/83 (for veterinary medicinal products, please read Article 53 of Directive 2001/82), the qualification level as well as the necessary professional experience of a QP is defined. The EU requirements as defined in these Directives have to be transferred to national law in each EU Member State. However, there are a number of differences in the EU Member States due to the fact that each Member State can implement the directives into national law with slight modifications.

答：指令2001/83的第49条（兽药参见指令2001/82第53条）中对QP的资质和必要的专业经验进行了界定。EU在这些指令里的要求已经通过国家法律转化为各成员国的要求。但是，由于各成员国实际情况有差异，因此可能会对指令具体实施要求略有不同。

Our recommendation is to discuss this matter with the respective authority in the Member State you plan to work as QP.

我们建议你与你准备作为QP工作的国家药监当局讨论此问题。

Q: Can companies outside the EU but with an MRA have a QP according the EU Directive. Can such a person be certified by the EU?
问：一个在欧盟领土之外的MRA持有人公司是否可以根据EU指令任命一位QP呢？该人员是否被EU认可？

A: Things that need to be considered are:

• The QP is linked to a European Manufacturing authorisation.
• If the "QP" is an employee of a company outside the EU, he/she is not employed by a company with an European manufacturing authorisation and therefore can not act as a QP.
• There is no such thing as a certification to be a QP. A QP is registered by the authority of the respective EU member state.
  

答：要考虑以下问题：

1.       QP是与欧洲生产许可相关的

2.       如果所谓的“QP”是一个欧盟以外公司的雇员，他/她并不由一个欧洲生产许可公司所雇佣，这种情况下是不能成为一个QP的

3.       并不存在什么持有QP证书的说法，QP是要由相关的欧盟成员国注册的

It is normal practice for a product manufacturer in a third country to have an EU-based importer who can provide the services of a QP? This EU-based QP would assess and certify a product/batch imported into the EU.

一般的做法是第三国药品生产商有一个在欧盟的进口商，由进口商提供QP服务，该EU内的QP会评估和出具证明给进口至欧盟的药品/批次。

Q: Does a QP from an EU Member State who is appointed by the Member State’s Main Pharmaceutical Inspectorate as a QP and is chemist and not a pharmacist can move to Germany and still carry out duties of QP?

问：如果一个欧盟成员国的QP被成员国的主要药品检查机构任命为QP，但是是化学师而不是药师，他是否可以转至德国仍担当QP职责呢？

A: Although the educational background would not be considered sufficient by the various local authorities in Germany to be initially accepted as a QP, a Chemist would be accepted once he/she is registered as a QP in another Member State. So once a QP is eligible and registered by another Member State authority he/she could apply as a QP in Germany. However it needs to be decided by the local German authority (e.g. Regierungspr?sidium or local government). Many Member States require that a QP speaks the local language to be able to understand batch records, certificates and other GMP-related documents.

答：尽管在德国，各药监当局会认为化学师的教育背景不足以被接受成为QP，但如果他/她在另一成员国注册成为QP，则在德国也会被接受。因此，只要一个QP在另一个成员国药监当局合法注册成为QP，那么在德国他也可以申请成为QP。但是，这还是要经过德国当地药监机构来决定（例如，市政局或当地政府）。许多成员国要求QP可以讲当地语言，可以读懂批记录、证书和其它GMP相关文件。

Q: If a company is based in Switzerland and produces pharmaceutical products, what are the possibilities to become a QP?
问：如果公司位于瑞士，生产药品，其雇员是否可能成为QP呢？

A: As Switzerland is not an EU Member State, the applicable Directives apply via the MRA.
The QP in Switzerland is called the "Fachtechnisch verantwortliche Person".
To become a Fachtechnisch verantwortliche Person, an academic qualification is needed (for finished products and intermediates usually a pharmacist). Other academic qualification is acceptable in case of proven experience and for APIs and blood products. The Notification is handled by Swiss Medic and the "Fachtechnisch verantwortliche Person" will be named on the manufacturing license. We would recommend contacting Swiss Medic for further information.

答：由于瑞士不是欧盟成员国，相关指令是通过MRA实施的。

瑞士的QP被称为“Fachtechnisch verantwortliche Person”（FvP）。

要成为FvP，需要具有学术教育背景（制剂和中间体一般要求是药师）。如果有被证明的工作经验，则其它学术背景也是可以接受的。对于原料药和血液制品，瑞士药监局有相关通知，FvP的姓名会被记载在生产执照上。我们建议与瑞士药监局联系获得更多信息。

Q: There are certain professional bodies in UK who can grant QP status and can advise people that they are eligible for QP status as per EU Directives. However, it appears that some Member States do not recognise the defined education and experience requirements for becoming a QP as per EU Directives. In France for example the 'Pharmacien Responsable' has to be a pharmacist qualified and registered in France. Is it possible to operate as a QP recognised by markets where our products are commercialised (all EU), while not being considered a QP by the country of manufacture?

问：在英国有一些专业团体，他们可以认证QP身份，可以告诉人们根据EU指令其具有法定的QP身份。但是，貌似有些成员国并不认可EU指令中所界定的QP所需教育背景和经验。例如，在法国，“'Pharmacien Responsable”必须具备药师资格并在法国注册。是否有可能按我们的药品销售区域（全欧盟），由其认可的QP来操作，而不考虑使用生产国QP呢？

A: Directives are only binding as to the result to be achieved– and leave national authorities the choice of form and methods. The EU requirements as defined in the Directives have to be transferred to national law in each EU Member State. However, there are a number of differences in the EU Member States due to the fact that each Member State can implement the directives into national law with slight modifications. This national law is the binding one. To operate as a QP one has to be named by the holder of the marketing authorisation in the EU and must be registered/ accepted by the EU member state where the company resides.

答：指令只是给出所要达到的结果，各国有自由选择自己的形式和方法来实施。在指令中所述的欧盟要求必须转化成为各欧盟成员国的国家法律才能实施，各成员国在实施时可以进行小的修订。该国家法律是必须执行的。要成为QP，必须由欧盟内的上市许可持有人提名，必须在公司所在欧盟成员国注册并被接受。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272014999344296/

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