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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
Welwyn Garden City
Welwyn Garden City is a town in Hertfordshire in the East of England region. It is located approximately 25 miles north of central London. Other towns and cities nearby include Luton which is 15 miles away, Watford 22 miles away, Hemel Hempstead 15 miles and Stevenage 10 miles. Welwyn Garden City was the second garden city in England and one of the first new towns. Welwyn Garden City's proximity to London and excellent transport links make it a convenient commuter town. Direct trains run to both Kings Cross and Moorgate stations in London as well as Cambridge and Peterborough.
Owned by the University of Hertfordshire, BioPark is a research and development facility providing specialist laboratories and conference facilities for bioscience, health technology, biopharmaceutical, contract research, medical technology and other biomedical businesses. The Tesco HQ is located in Welwyn Garden City.
Famous people from Welwyn Garden City: Nick Faldo, Golfer and Alesha Dixon, singer