HEMEX wants to facilitate your daily work as much as possible so you can focus on your core competencies. HEMEX offers therefore different scalable QP-services to fulfill your required QP-tasks.
Fachtechnisch verantwortliche Person
Every company holder of a GMP manufacturing license or applicants are required by law to have a responsible person (or commonly qualified person, QP).
The QP is responsible to ensure compliance with the relevant regulations of the pharmaceutical law for the manufacture, import, wholesale and export, trade abroad and release of medicinal products. The responsible person is also responsible for the compliance with legal regulation of the complete manufacturing documentation. The duties of the QP are described in detail for each type of authorization in the Medicinal Products Authorization Ordinance (AMBV)*.
The function of the QP is demanding and associated with far-reaching obligations. Appropriate professional experience and relevant knowledge are therefore indispensable. To fulfill this task, the QP needs to have a natural sciences education as well as several years of professional experience within the pharmaceutical industry. Further criteria concern the language and the domicile. The QPs main task is to ensure that the company’s GMP activities take place within the framework set by the regulatory authorities.
HEMEX is able to provide part time QP-expertise, while our highly qualified QPs are proficient in English and the required national language German and French.
The direct supervision by a part-time QP is understood as the supervision of at least all critical steps/operations about the company’s GMP processes. The company maintains a current list of critical steps/operations for which the QPs presence on site is mandatory. Based on this list, the minimum hours of presence is set. This list will also help the license holder/applicant to fulfil the requirement of having a purposeful operative organization.
A QP is therefore required by law and mandatory for license holder and applicants for GMP-manufacturing license. He is responsible for the quality of the medicinal products manufactured and ensures compliance with the provisions of medicinal product law. Don’t hesitate to contact HEMEX for your individual advice on this legal topic.
* Therapeutic Products Act (SR 812.21) and Medicinal Products Licensing Ordinance (SR 812.212.1), article 5, article 6, article 17, article 18, article 22, article 23, article 25, article 26 and article 39