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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
The East of England
The East of England (aka East Anglia) is one of the nine official regions of England. It consists of Bedfordshire, Cambridgeshire, Essex, Hertfordshire, Norfolk and Suffolk.
Major towns and cities in the East of England include Bedford, Bishop’s Stortford, Borehamwood, Cambridge, Colchester, Harlow, Ipswich, Leighton Buzzard, Huntingdon, Luton, Norwich, Peterborough, Stevenage, and Watford.
The East of England region has a strong history of industrial and scientific innovation and success, examples of which include the first heart transplant in the UK and the discovery of the structure of DNA. There are numerous science parks in and around Cambridge which are home to biotech, life science and clinical research companies. The proliferation of high technology companies has led to the area being dubbed “Silicon Fen”. Logistics is also a major employer in the region thanks to Luton and Stansted airports and the ports of Harwich and Felixstowe.
Famous people born in the East of England region: Ralph Fiennes, actor and Jamie Oliver, TV chef