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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
Cambridge is a picturesque university city on the River Cam in Cambridgeshire approximately 50 miles north east of London and within commutable reach of Bedford, Newmarket and Peterborough. Transport links are excellent as the city is close to the M11 and A14. Cambridge station is less than an hour from London King's Cross. The University of Cambridge, founded in 1209, comprises 31 colleges and regularly ranks as one of the top five universities in the world. The university is closely linked with the development of the high-tech business cluster known as "Silicon Fen" which is home to numerous software and Bioscience start-ups and to Cambridge Biomedical Campus, one of the largest Biomedical research clusters in the world. With its stunning architecture, galleries and museums and lovely riverside setting, the city is a very popular tourist destination.
Famous people born in Cambridge: Richard Attenborough, actor and director, Douglas Adams, writer (author of The Hitch Hiker’s Guide to the Galaxy)