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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
Worthing is a large seaside town located in West Sussex in South East England. The cities of Brighton and Chichester are close by and London is only 50 miles away. Worthing is a great place to live and work with good schools and transport links as well as a pier, sports facilities, a theatre, cinemas and a wide variety of shops, restaurants and bars. Worthing also benefits from being located at the foot of the South Downs, the UK’s most recent National Park, which offers fabulous scenery, marked trails for walking, horse riding and mountain biking. Worthing was first inhabited in the Bronze Age, became a farmstead in the Roman era and remained a small agricultural fishing village for centuries after that. Thanks to Princess Amelia, who decided to visit Worthing in 1798 to help her recuperate from TB, Worthing became a fashionable destination for wealthy members of London’s Society to try out the beneficial effects of bathing in the sea. Tourism is still a major employer in Worthing together with pharmaceuticals, medical devices production and financial services.