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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
Cranleigh, which is situated in Surrey in the South East Region, is reputedly the largest village in England. Cranleigh is located approximately 50 miles from London, 8 from Guildford, 12 from Horsham and 9 from Dorking. Although there are some light engineering companies in Cranleigh, many residents commute to London, Guildford and other larger towns. The Beeching railway cuts meant that Cranleigh lost its station in 1965 and the nearest one is now in Chilworth, approximately 8 miles away. Cranleigh is surrounded by beautiful open countryside and is close to Petworth House, Winkworth Arboretum and Leith Hill.
Cranleigh is famous for two main reasons. Firstly, in 1859 it was the first place to set up a cottage hospital and secondly the head of a grinning cat is carved on an arch in the church and this is believed to have been the inspiration for Lewis Carroll's Cheshire Cat.
Famous people from Cranleigh include: Anna Botting, Sky News Presenter and W Heath Robinson, Cartoonist & Illustrator