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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
Burgess Hill is a town located in West Sussex in the South East of England. Burgess Hill is located approximately 39 miles from London and 10 miles from Brighton. Other major towns in the area include Haywards Heath, Lewes, Horsham and Crawley. Burgess Hill has excellent road and rail links to Brighton and London and is only 16 miles away from Gatwick Airport. Although many Burgess Hill residents do commute to London, Brighton and other cities, global companies including Filofax, Roche Diagnostics and American Express have large offices in Burgess Hill and as a result are major employers and contributors to the local economy n Burgess Hill.
Burgess Hill is a great base for exploring many interesting historical Burgess Hill sites including castles such as Lewes, Bodiam and Arundel beautiful gardens amongst which are Nymans, Borde Hill, Wakehurst Place and Sheffield Park. The South Downs National Park, which offers great walking, cycling and horse riding trails is also within easy reach of Burgess Hill.
Famous people from Burgess Hill:- Simon Nye, TV writer (Men Behaving Badly, The Durrells) and holly Willoughby, TV presenter