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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
Stevenage is a town in Hertfordshire approximately 35 miles north of London. Although there is evidence of a Roman settlement, Stevenage grew very slowly over the centuries. However, in 1946 Stevenage was designated Britain’s first “New Town” which meant six neighbourhoods being developed to help resolve the UK’s post-war accommodation problems. Opened by the H.M. the Queen in 1959, Stevenage's pedestrianised town centre was the first traffic free shopping zone in Britain. From a business point of view, Stevenage has become a centre for Life Sciences thanks to the Stevenage Bioscience Catalyst which aims is to support the next generation of pharma and biotech companies by offering access to equipment and facilities and in so doing placing the UK bioscience sector at the forefront of worldwide biomedical innovation. More recently Stevenage has become famous for the annual rock and pop festival held at Knebworth.
Famous people born in Stevenage: Lewis Hamilton, F1 motor racing world champion and Ian Poulter, professional golfer