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QPThe Qualified Person is a person who performs the activity of certifying batches of medicines before they are sent to wholesalers and/or pharmacies. It is therefore the last activity (considered as manufacturing activity) before the medicines are made available to patients. This certification is valid throughout the European Union.

The responsibility of the Qualified Person is therefore important because he must ensure that each lot taken individually has been manufactured and checked in accordance with the law in force in the Member State, with the authorization to place it on the market and in accordance with Good Manufacturing Practices (GMP). This also applies in the clinical field for which the medicinal product does not have a marketing authorization yet but must meet other requirements.

Every Qualified Person has a unique number assigned to him by the Minister of Public Health and is included in the official list of Qualified Persons published in the Belgian Official Gazette (see Articles 84 and 211 of the Royal Decree of 14/12/2006 relating to medicines for human and animal use).

In order to be approved as a Qualified Person, the Industrial Pharmacist must complete a minimum 6 months internship in one or more companies established in Belgium or in the European Union. 

These companies must be holders of a permit to manufacture medicinal products issued by the competent authorities. The internship will include manufacturing activities and qualitative and quantitative analysis of medicinal products.

The Qualified Person is the contact person for the competent authorities (inspections, batch recalls, quality problems, unavailability, ...).