Duties of the Responsible Person

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Jun 14

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.

Unsure if you are knowledgeable enough to be the RP?

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