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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
Lancashire is a county in the North West region of England. Major towns and cities in Lancashire include Blackburn, Bolton, Burnley, Bury, Lancaster, Oldham, Preston, Rochdale and Wigan. During the Industrial Revolution Lancashire became a major industrial region with much of its wealth deriving from the textile production, especially cotton and coal mining. Manufacturing still makes an important contribution to the economy, but the areas of specialisation now include Defence, nuclear power, vehicles and food products. The seaside resort of Blackpool has been a popular destination for days out and weekends away since the days of the Industrial Revolution when the mills were at their peak production. The mill workers would visit during their “wakes” week in the summer and Blackpool Tower, the illuminations and the ballroom still draw large numbers of visitors. Lancashire is famous for its hearty cuisine with such delicacies as Lancashire Hotpot, Eccles cakes, Parkin and the town of Mossley near to Oldham claims to have been the birthplace of the first fish and chips shop in northern England.
Famous people born in Lancashire: Peter Kay, comedian and Victoria Wood, comedian