Responsible Person
The EU GDP Guidelines (2013/C 343/01) for Good Distribution Practice of Medicinal Products for Human Use require wholesale distributors to appoint a Responsible Person (RP).
The responsibilities of the responsible person 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.
QualiPharm are based near Edinburgh in Scotland and can provide contract RP services to clients in UK, Ireland and the rest of the EU.
The responsibilities of the responsible person 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.
QualiPharm are based near Edinburgh in Scotland and can provide contract RP services to clients in UK, Ireland and the rest of the EU.