欧洲QP协会问答： 合同QP

欧洲QP协会问答： 合同QP  

2014-11-10 11:47:08|  分类： 欧盟知识|

Contract Qualified Persons 合同QP

Q: Is there any guidance available defining “sufficient” time on a site to familiarise a Contract QP with the Quality System? 是否有定义在现场“足够长”时间的指南说明合同QP对质量体系的熟悉程度？

A: There is no guidance available. The time on site will depend on the complexity of the quality system. An important consideration is the maturity and stability of the system. If the system is mature and stable a shorter time on site may be indicated, provided that the contract specifies that the QP must be made aware of any changes that affect the quality system.

答：没有这样的指南。在现场的时间取决于质量体系的复杂程度。一个重要的考虑点是系统的成熟度和稳定性。如果合同里说明QP必须明白对质量体系有影响的所有变更，而如果系统是成熟稳定的，则可能表示在现场的时间可以相对短。

Q: Outsourcing the QP batch release: 外包QP批放行
- what are the pre-requisites (GMP and legal)?  前提是什么（GMP和法定要求）？
- what experience is needed?  要求什么经验？
- are there any existing models as a reference?  是否有现成的样例作为参考？

A: The QP must be endorsed by the competent local authority according to the national law. There must be a written agreement between the QP and the manufacturer, clearly describing the role and responsibility. The permanent availability of the QP must be assured, the frequency of on-site availability and the way the QP gets all relevant information must be defined. The QP must be appropriately experienced in the manufacture and quality control of the product type manufactured by the contract giver. In case the products need additional formal education or experience – like with regard to blood products, the QP must comply with these requirements.

答：QP必须由当地药监当局根据国家法律认可。QP和生产商之间必须有书面协议，其中清楚描述其作用和职责。必须保证QP能稳定地实施其职责，要定义出现在现场的频次及QP获得所有相关信息的途径。QP必须具备合同委托方产品类型方面适当的生产和质量控制经验。如果产品需要更多的正式教育或经验---例如，血液制品，QP必须符合这些要求。

Q: When IMPs are imported from outside the EU; how could I set up a working relationship as a contract QP when it comes to liability and insurance? 在IMP从EU以外地区进口时，在讨论连带责任和保险时，我要怎么来订立合同作为合同QP工作？

A: As a contract QP you are a “normal” contracting party (i.e. just like any other service provider for the company but with the specific legal responsibilities and risks of a QP) and therefore no employee of the company. That means that you are not covered by any of the insurance programmes which companies usually provide for their employees (e.g. D&O insurance). As a result, you should mention that fact – and the related legal risks – during your contract negotiations with the company.

答：作为合同QP，你是一个“正常”的合同方（即，就像其它给公司提供服务的一方一样，但是具有特定的法律责任和作为QP会有风险），因此不是公司的雇员。这表示你不会被包括在任何的保险计划中，一般公司会给他们普通员工提供一定的保险（例如D&O保险）。这样，你应该在与公司讨论合同内容时谈到这个情况----及相关的法规风险。

Ideally, there should be an indemnification clause in the service contract providing for that ‘the company indemnifies the contract QP from any and all third party claims related to the services which the contract QP may perform under the service contract’. If your current contract does not contain such provision, you should ask the company to sign an amendment with aforesaid clause.

理想的做法是，在服务合同中有一个赔偿条款，“公司应负责赔偿QP根据服务合同提供相关服务给任何第三方时与服务相关的索赔”。如果你现在的合同没有包括这类条款，你应该要求公司签证一份补充条款，加入上述内容。

You can also ask the company to get yourself explicitly included in its D&O insurance contract (some insurers may actually be ready to do so because of the specific situation of the contract QP).This inclusion could be the first part of the contractual provision, followed by the indemnification clause mentioned above.

你也可以要求公司清楚说明将你包括在其D&O保险合同中（有些保险人实际可以这样做，因为合同QP是比较特定的情形）。这可以包括在合同条款的第一部分，在上述赔偿条款之后。
（来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272014101011478509/）

好资料，感谢分享