The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the role and the responsibility of the RP. Therefore we have put together some information on this webpage.
The MHRA summarizes the responsibility of the RP as follows:
“The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include:
to ensure that the provisions of the licence are observed
to ensure that the operations do not compromise the quality of medicines
to ensure that an adequate quality system is established and maintained
to oversee audit of the quality system and to carry out independent audits
to ensure that adequate records are maintained
to ensure that all personnel are trained
to ensure full and prompt cooperation with product licence holders in the event of recalls.
In order to carry out his duties, the RP should have a clear reporting line to the licence holder or MD. The RP should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas, etc. and the standards achieved.”
The ECA Academy is organising a regular training course on
the Responsible Person for Good Distribution Practices (GDP) for colleagues who want to lean more about the requirements, role and responsibilities of the RP.
In the following you will find the requirements of the RP as defined in the
EU GDP Guideline of 5 November 2013 (Section 2.2)
“The wholesale distributor must designate a person as responsible person. The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned. A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.
The responsible person should fulfil their responsibilities personally and should be continuously contactable. The responsible person may delegate duties but not responsibilities.
The written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. The wholesale distributor should give the responsible person the defined authority, resources and responsibility needed to fulfil their duties.
The responsible person should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
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”