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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
Reading is a large town located at the confluence of the river Thames and the River Kennet in Berkshire, approximately 25 miles from Oxford, 42 miles from London and 17 miles from Basingstoke. Reading was established in the 8th century as a market town and became prosperous over the following centuries thanks to its cloth, iron works, breweries, bulbs/seed and biscuit industries. In the 20th century the town continued to expand and is now a significant business centre and home to the UK offices of a significant number of global Pharmaceutical, Life Science and IT companies. The town has become famous for its annual Reading Festival held over the August Bank Holiday weekend and attended by thousands of music lovers.
Famous people born in Reading: Ricky Gervais (comedian) and Kate Winslet (actress)