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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
Swindon is a town in Wiltshire, in the South West region of England. It is located approximately 35 miles from both Bristol and Reading and 78 miles from London. Other major towns within reasonable distance include Oxford, Cheltenham and Salisbury. Swindon is on the main railway line from Bristol to London Paddington and, with an average journey time of only 1 hour to London, it is a major commuter town. Road connections are also good, thanks to the proximity of the M4 motorway. Although many residents commute to London, Bristol and other cities, a substantial number of major employers are located in Swindon including engineering firms such as Honda, BMW/Mini and Halcrow as well as W H Smith's HQ and distribution centre and pharmaceutical companies including Patheon, Catalent Pharma Solutions and Vygon (UK) Ltd. Swindon also has the head office of the National Trust, the UK Space Agency and national Research Councils including the Biotechnology and Biological Sciences Research Council.
Swindon has two major museums; the STEAM Museum which provides a detailed history of the Great Western Railway and the Museum of Computing, it is also home to the Bodleian Library's book depository, which contains 153 miles of bookshelves
Famous people from Swindon: Billie Piper; actress and Melinda Messenger; glamour model and TV presenter