The Qualified Person has one task, but a very important one! Namely to ensure that each batch of medicinal products has been manufactured according to GMP guidelines and is checked in compliance with the requirements of the Marketing Authorization.
If you’re producing or importing pharmaceuticals you need a Qualified Person in order to confirm that each batch is made according to the proper Good Manufacturing Practices (GMP) and Marketing Authorization (MA). The services of a QP must be permanently and continuously at your disposal: that means 24-7. That’s the law! So, you are obliged to arrange cover for time off and holidays!
Can anyone be appointed as your Qualified Person? The answer is no! Your appointed person must be appropriately qualified and, if you’re based in Belgium, approved by the Competent Authorities and registered on a list of authorised persons, published in the Belgian State Journal. A relevant degree in industrial pharmacy is a must. Your chosen person may be an employee or someone external.
Once your choice is made, you must officially notify the FAMHP (Federal Agency for Medicines and Health Products) who will take responsibility for your company. It is also advised that you indicate who will act as your backup QP.
A Responsible Person has a very varied range of tasks within a Good Distribution Practice (GDP) organisation. Their responsibilities must be fulfilled personally and, like a qualified person, they must be contactable around the clock. They may delegate their tasks, but never their responsibilities.
Their tasks include:
(i) ensuring that a quality management system is implemented and maintained
(ii) focusing on the management of authorised activities and the accuracy and quality of records;
(iii) ensuring that initial and continuous training programmes are implemented and maintained;
(iv) coordinating and promptly performing any recall operations for medicinal products;
(v) ensuring that relevant customer complaints are dealt with effectively;
(vi) ensuring that suppliers and customers are approved;
(vii) approving any subcontracted activities which may impact on GDP;
(viii) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
(ix) keeping appropriate records of any delegated duties;
(x) deciding on the final disposition of returned, rejected, recalled or falsified products;
(xi) approving any returns to saleable stock;
(xii) ensuring that any additional requirements imposed on certain products by national law are adhered to
If you are holding, supplying or exporting pharmaceuticals, you are required by law to employ a Responsible Person (RP). As a wholesale distributor, you are obliged to possess a wholesale distribution authorization and you need to comply with GDP. Again, the Responsible Person must be continuously contactable, which means you will almost certainly need a backup to help you when your usual RP is absent or on holiday.
Can you choose anyone to be a Responsible Person? No! The Responsible Person requires particular pharmaceutical, medical or scientific qualifications, determined by law, plus the appropriate competence and experience, as well as a knowledge and training in GDP.
As with Qualified Persons, you are obliged to tell the FAMHP (Federal Agency for Medicines and Health Products) who will take responsibility for your company, as well as who will be your backup RP.