The Responsible Person has defined duties and responsibilities.
EU Guidance 2013/C 343/01 lists them as follows;
• ensuring that a quality management system is implemented and maintained;
• focusing on the management of authorised activities and the accuracy and quality of records;
• ensuring that initial and continual training programmes are implemented and maintained;
• coordinating and promptly performing any recall operations for medicinal products;
• ensuring that relevant customer complaints are dealt with effectively;
• ensuring that suppliers and customers are approved;
• approving any subcontracted activities which may impact on GDP;
• ensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged programme and necessary corrective measures are put in place;
• keeping appropriate records of any delegated duties;
• deciding on the final disposition of returned, rejected, recalled or falsified products;
• approving any returns to saleable stock;
• ensuring that any additional requirements imposed on certain products by national law are adhered to
Duties may be delegated to a suitably trained person, however ultimate responsibility remains with the Responsible Person or the licence holder if different.
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