近日，欧盟成员奥地利当局发布了质量受权人（QP）相关的问答，对质量受权人聘用、转授权等活动，以易于理解的方式进行了解释：

 

Does a Qualified Person in accordance with § 7 AMBO 2009 have to be permanently employed? What is the lowest possible level of service?

 

质量受权人是否必须长期受雇？最低服务级别是多少？

 

On the basis of the relevant provisions of the AMBO 2009, from the perspective of the BASG it must be stated that the Qualified Person is a dependent employee of the company. It is precisely the required organisational integration into the company, including the obligation to follow instructions, in particular with regard to working hours, the lack of own operating resources etc., that draws a clear line to self-employment. The employment relationship of the Qualified Person has to be assessed according to the individual area of responsibility in the company and may deviate from a full-time employment relationship in individual cases. Exceptions are considered only appropriate for  small companies in which, due to the activity to be carried out and the responsibility of the Qualified Person, an employment relationship of the type described would be disproportionate to the company . This must be demonstrated by the company in each individual case and decided by the BASG.

 

根据 AMBO 2009 的相关规定，必须声明质量受权人（QP）是公司雇员。需要融入公司的组织架构，包括分配需要遵守的义务，特别是工作时间、经营资源等方面，这与自由职业划清了界限。QP人员的雇佣关系必须根据公司的个人职责范围进行评估，在个别情况下可能会偏离全职雇佣关系。例外情况被认为仅适用于小型企业，在这些公司中，由于要开展的活动和QP的责任，全职类型的雇佣关系也许与公司不成比例。这必须由公司在每个个案中证明，并由BASG 决定。

 

May responsibilities of a Qualified Person be delegated?

 

QP的职责可以被委托吗？

 

The release of a batch of medicinal products must be carried out by a Qualified Person. The Qualified Person may only delegate the tasks incumbent on him/her to another Qualified Person. See also Annex16 to the EU-GMP (Certification by a Qualified Person and Batch Release) guidelines.

 

药品的放行必须由QP人员进行。QP只能将其所承担的任务委托给另一位QP。另请参阅 EU-GMP指南附录16（QP人员认证和批放行）。

 

Can an external consultant take over activities of the Qualified Person?

 

外部顾问可以接管QP的活动吗？

 

No. In principle, the Federal Office for Safety in Health Care considers an employment relationship in the form of a contract of employment to be necessary (other forms of employment law such as a "contract for work and labour" or a "free service contract" are thus excluded).

 

不。原则上，当局认为雇佣合同形式的雇佣关系是必要的。

来源：Internet

关键词： 质量受权人