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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 an RP
- 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
Oxfordshire is a county in South East England, to the north west of London. Major towns and cities in Oxfordshire include Oxford, Banbury, Bicester, Witney, Thame, Abingdon, Wantage, Didcot, Harwell, Wallingford and Henley-on-Thames. Oxfordshire has the largest concentration of research and development activity in Western Europe. Harwell Oxford Campus, part of Science Vale Oxford UK, is being developed as a world-class centre for science, innovation and enterprise. Milton Park is of the UK’s foremost science communities, housing companies ranging from start-ups to global organisations with particular strengths in the biotechnology and ICT sectors. Education and tourism are major employers in Oxfordshire. Tourist attractions in Oxfordshire include the stunning city of Oxford, Blenheim Palace, Henley-on-Thames, Bicester Shopping village and numerous attractive towns dotted along the river Thames.
Famous people born in Oxfordshire: Winston Churchill, former Prime Minister and Stephen Hawking, theoretical physicist.
The Oxforedshire Life Sciences and Healthcare ckuster spans a whole range of life sciences enterprise including drug discovery and development, diagnostics, medical devices, digital health, regenerative medicine, precision medicine and genomics. With world-leading research and teaching providing the ideas and talent to develop ground-breaking new technologies, we also operate as a global powerhouse for clinical trials.
Oxfordshire is a major site for biotechnology, rare disease, ATMP, cell therapy, gene therapy and pharmaceutical development. It houses a number of university spin-out businesses, start-up biotechs and other organisations attracting seed investment. If you are looking for career opportunities in life sciences within the Oxford, call the Next Phase Recruitment team on 01403 216216.