Duties of the Responsible Person

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10
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?

Worried that you don’t know how to fulfill these core duties/responsibilities?

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