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The MHRA and the European GDP Guideline of 5 November 2013 require that, in order to gain and retain a Wholesale Dealer’s Licence (WDA) licence, wholesale pharmaceutical distributors must designate a Responsible Person (RP) for Good Distribution of Medicinal (GDP) who must be named on the licence. The responsibilities and liabilities of the RP remain the same whether the Responsible person is employed directly by the licence holder or is an independent contractor.
According to the MHRA, the RP is responsible for “safeguarding product users against potential hazards arising from poor distribution practices”. The duties and responsibilities of a RP includeensuring that the provisions of the licence are fulfilled by means of GDP and GMP compliance and best practice within all regulated activities, a compliant quality system is established and maintained and a suitable document control system is in place to ensure that adequate records are maintained. In addition, the RP will need to oversee the audit of the quality system, carry out independent audits and cooperate with the product licence holder and regulatory authorities with regard to drug returns and product recalls.
In order to carry out his/her duties, the RP should have knowledge of the products being traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas and records which relate to the licensable activities and regularly review and monitor all such areas.
Skills and Experience required to become an RP
- Degree in pharmacy (preferable) or Qualified Person status
- Practical experience in Supply Chain, Production and Quality Assurance relating to the distribution of medicinal products
- Extensive knowledge of GDP and GMP
- Experience of hosting MHRA inspections, client audits and self-inspections
- High level of accuracy
Essex is a county located to the north-east of London in the East of England region. Major towns and cities in Essex include Colchester, Chelmsford, Basildon, Harlow, Romford and Southend. Much of Essex is agricultural land, but the south has a concentration of industries including electronics, life science, pharmaceuticals, engineering and services. Thanks to its close proximity to London and Cambridge Essex has been able to develop as a high-tech cluster for research and development in industry sectors including Life Sciences, healthcare and renewable energies. As home to both Stansted and Southend airports as well the ports of Tilbury, Harwich and the UK’s largest container terminal in Thurrock, the Logistics industry is also a major employer in Essex.
Essex has 350 miles of coastline with windswept saltmarshes and tidal inlets which are rich in wildlife in contrast to traditional seaside resorts with piers at Southend and Clacton. Other popular visitor attractions in Essex include Colchester with its Roman remains, castle and zoo, numerous National Trust houses and gardens and Lakeside shopping centre.
Famous people born in Essex: Jamie Oliver, TV chef and Russel Brand, comedian