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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
Kent is a county in South East England, to the south east of London. Major towns and cities in Kent include Canterbury, Sevenoaks, Maidstone, Ashford, Folkestone, Tonbridge, Tunbridge Wells, Dartford, Gravesend, Sittingbourne, Faversham, Deal and Dover. France, which on a good day, can be seen clearly from Folkestone and the White Cliffs of Dover, lies across the Channel and is easily reached by regular ferry services from ports including Dover and Folkestone.
Kent has a very diverse economy with major industries including haulage, logistics, tourism, technology and scientific research. With its good transport connections many people also commute into London. Tourist attractions in Kent include Canterbury Cathedral which has been the seat of the Archbishop of Canterbury since the 6th century, HM dockyard Chatham and numerous castles.
Famous people born in Canterbury: Orlando Bloom and Mick Jagger, musician