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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
Guildford is a large and attractive town located in Surrey in South East England, approximately 30 miles south west of London, 12 miles from Farnham, 10 miles from Woking and 22 miles from Horsham. Guildford is within easy reach of Heathrow and Gatwick Airports, has excellent rail links to London and easy access to the M25, M3 and A3, making it a very desirable place to live and work. The Royal Grammar School, founded in 1509, was attended by John Derrick who, in 1597, made the first written reference to cricket being played anywhere in the world. On Guy Fawkes Nights from 1820 – 1865 gangs of local men wearing masks and disguises would run riot, breaking into the houses of people who had annoyed them during the year, stealing their possessions and throwing them onto a bonfire. These days Guildford is rather more peaceful and offers a wide range of shops, restaurants and pubs as well as the renowned Yvonne Arnaud theatre, several cinemas and riverside walks.
Famous people born in Guildford: Piers Morgan, journalist & TV personality and Tony Blackburn, DJ