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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
Bathgate is a small town in West Lothian, Scotland situated 18 miles from Edinburgh, 23 miles from Glasgow and 9 miles from Livingston, benefitting from its proximity to the numerous electronics and hi-tech companies based in the “Silicon Glen”. Bathgate's origins date back to the 1100s. In 1328 Robert the Bruce gave the Royal Castle in Bathgate to his daughter Marjorie on her marriage to Walter, the High Steward of Scotland which was the start of the Stewart dynasty that ruled Scotland until 1689. The town has experienced repeated periods of growth and decline throughout its history including the Glenmavis Distillery, steelworks, coalmining, the world's first oil refinery and in more recent times, the motor and electronics industries. On the last Saturday in May Bathgate hosts annual the West Lothian Highland Games, it also features in the chorus of the Proclaimers' song "Letter from America."
Famous people from Bathgate: David Tennant (Actor)