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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
Hampshire is a large county on the south coast of south east England. Major towns and cities in the county include Southampton, Portsmouth, Fareham, Farnborough, Farnham, Gosport, Andover, Basingstoke, Aldershot and Winchester which was the capital city of England in days gone by.
Hampshire is the birthplace of the Royal Navy, British Army and Royal Air Force and Portsmouth is still home to a large Royal Navy base. Portsmouth and Southampton are amongst the largest ports in Europe and as a result, the logistics industry is a major employer in the county. Other industries that are prominent in Hampshire include aerospace, defence, financial, ICT and digital media, the latter particularly around Basingstoke in the north of the county. Hampshire's has many tourist attractions including the New Forest, the South Downs, Winchester Cathedral, the National Motor Museum at Beaulieu, Thruxton motor racing circuit and the annual Farnborough air show.
Famous people born in Hampshire: Jane Austen and Charles Dickens, both authors