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近日，歐盟成員奧地利當局發(fā)布了質(zhì)量受權(quán)人（QP）相關(guān)的問答，對質(zhì)量受權(quán)人聘用、轉(zhuǎn)授權(quán)等活動，以易于理解的方式進行了解釋：

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

質(zhì)量受權(quán)人是否必須長期受雇？最低服務(wù)級別是多少？

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.

根據(jù) AMBO 2009 的相關(guān)規(guī)定，必須聲明質(zhì)量受權(quán)人（QP）是公司雇員。需要融入公司的組織架構(gòu)，包括分配需要遵守的義務(wù)，特別是工作時間、經(jīng)營資源等方面，這與自由職業(yè)劃清了界限。QP人員的雇傭關(guān)系必須根據(jù)公司的個人職責范圍進行評估，在個別情況下可能會偏離全職雇傭關(guān)系。例外情況被認為僅適用于小型企業(yè)，在這些公司中，由于要開展的活動和QP的責任，全職類型的雇傭關(guān)系也許與公司不成比例。這必須由公司在每個個案中證明，并由BASG 決定。

May responsibilities of a Qualified Person be delegated?

QP的職責可以被委托嗎？

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.

藥品的放行必須由QP人員進行。QP只能將其所承擔的任務(wù)委托給另一位QP。另請參閱 EU-GMP指南附錄16（QP人員認證和批放行）。

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

外部顧問可以接管QP的活動嗎？

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。原則上，當局認為雇傭合同形式的雇傭關(guān)系是必要的。