Our quality assurance experts assume responibility for your product development, while complying with cGxP quality standards. Our QP services include site audits, supply chain management, quality oversight and batch release.
Fachtechnisch verantwortliche Person
Every company holder of a cGMP manufacturing license or applicants are required by law to have a responsible person (or more commonly known as Qualified Person, QP).
The QP is responsible to ensure compliance with the relevant regulations of the pharmaceutical law for the manufacture, import, wholesale, export, trade abroad and release of medicinal products. The responsible person is also liable for compliance with the required 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. 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. The QPs main task is to ensure that the company’s GMP activities take place within the framework set by the regulatory authorities.
HEMEX can provide part time QP-expertise, whilst our highly qualified QPs are proficient in English and the required national languages German and French.
The direct supervision by a part-time QP is understood as the supervision of at least all critical steps/operations surrounding the company’s GMP processes. The company maintains a current list of critical steps/operations during which the QPs presence on site is mandatory. This list defines, the minimum hours of QP presence required. 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 to license holders and applicants for the GMP-manufacturing license. They are responsible for the quality of the medicinal products manufactured and ensure compliance with the provisions of medicinal product law.
* 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