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RP/Responsible Person

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 

Wilmslow

Wilmslow is a small town in Cheshire in the North West region of England.  Wilmslow is located in an affluent area including Mottram St. Andrew and Alderley Edge known locally as the Golden Triangle which is one of the most expensive and desirable places to live in the UK and is favoured by footballers and celebrities.   Once the railways arrived in the Victorian era providing good connections to cities including Manchester, Liverpool and Macclesfield the area became desirable as a place of residence for wealthy North West businessmen.

Local employment is provided at the HQ of clothing giant Umbro, the Information Commissioner’s Office and Alderley Park which is home to the UK’s largest bioscience park and one of three campuses comprising MSP a major provider of support to science and technology companies. 

Wilmslow also offers easy access to great leisure opportunities including the world-famous Manchester United and Manchester City football stadiums, the Peak District National Park and Quarry Bank, a museum of the cotton industry which dominated the area during the Industrial Revolution.

Famous people from Wilmslow:  Alan Turing, mathematician and creator of a machine that cracked the Enigma code during WW2 and Sir Alex Ferguson, Manager of Manchester United for many years.