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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
Manchester is a world class city in north-west England with excellent transport links including an international airport, the Manchester Ship Canal and easy access to the national motorway network. Manchester was initially settled by the Romans, growing slowly during the Middle Ages and then rapidly around the turn of the 19th century, thanks to the textile industry, making it the birthplace of the Industrial Revolution. The city continues to be an industrial and commercial powerhouse. Manchester’s current strengths include Life Sciences, Manufacturing and Creative/Digital media. Several medical research institutes and Europe’s biggest cancer treatment are located in Manchester as are numerous innovative software development, augmented reality, digital health, e-commerce and gaming companies.
The biological, medical and health sciences have a long and proud history at the University and in the city of Manchester.
Manchester is a place of world-firsts in cancer research, including the first clinical use of Tamoxifen for breast cancer and the first single harvest blood stem-cell transplant.
The study of medicine at Manchester can trace its roots back to 1814, when Joseph Jordan opened a school of anatomy in the city. From 1824, numerous medical schools opened in the city which, in 1836, amalgamated to form the Manchester Royal School of Medicine and Surgery, employing well-known names such as John Dalton, Edward Lund and Rochard Hunt. It was also in 1824 that the study of pharmacy began at Manchester Medical School.
The study of life sciences at Manchester goes back to 1851, when Owens College was founded and William Crawford Williamson was appointed as professor of natural history with teaching responsibilities for botany, ohysiology, geology and zoology.
The Museum of Medicine and Health holds a significant collection of medical, nursing and pharmaceutical artefacts dating as far back as the 16th century.
Famous people from Manchester:- Noel & Liam Gallagher (Oasis) and Emmeline Pankhurst – Suffragette/Women’s rights activist