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Responsible Person (RP)

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 a Responsible Person

  • 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 

Greenford

Greenford is located in the London Borough of Ealing in north west London.  Towns and suburbs close to Greenford include Harrow, Brentford, Hayes, Watford and Slough.  Greenford is on the Central Line of the London Underground and also has overground rail connections into central London.  Road connections are also good as Greenford is located on the A40 which leas out to the M40 and then onto the M25, Heathrow Airport is on 12 miles away.  Greenford is well-located for a number of leisure-time places of interest including the world-famous Wembley Stadium and Wembley Arena, both of which are only 3 miles away.   Two excellent museums are also in the Greenford area; the London Motorcycle Museum, which has a wide range of bikes & memorabilia on display, and the Musical Museum which has a huge collection of self-playing musical instruments ranging from very small clockwork music boxes to huge “Mighty Wurlitzer” organs.   

Famous people from Greenford: Jourdan Dunn, model and Steven Warner, actor