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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
Leighton Buzzard is a town in Bedfordshire in the East of England region, lying approximately 15 miles from both Luton and Milton Keynes, 30 from Northampton and 55 from central London.
Leighton Buzzard is the location of Europe’s largest battery, housed in a huge facility where electricity is converted from AC to DC in one room and stored in another room in a trial being undertaken to assess the viability of storing energy so that it can be used during periods of peak demand. If successful, battery storage could be added to solar, wind and tidal power as alternative sources of energy. Leighton Buzzard’s other main claim to fame is the Leighton Buzzard Light Railway, a narrow gauge heritage railway. The main employment sectors in the Leighton Buzzard area include engineering quarrying.
Famous people from Leighton Buzzard: Kajagoogoo, 1980’s pop band and Mary Norton, writer author of “The Borrowers” and “Bedknobs and Broomsticks”