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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
Lying on the river Tywi, Carmarthen is the county town of Carmarthenshire in Wales and is located approximately 30 miles from Swansea and 70 miles from Cardiff. The town was founded by the Romans and 1000 years later Carmarthen Castle, built by the Normans, became their regional capital. In the 19th century the development of the coal mining industry meant that growth moved away from Carmarthen to other areas in South Wales. The main industries in Carmarthen today are agriculture, fishing, forestry and tourism. The town is within easy reach of the Brecon Beacons National Park and the beautiful Pembrokeshire coast as well as many other visitor attractions including the Dylan Thomas Boathouse in Laugharne, Kidwelly Castle, the National Wool Museum and the Dolaucothi Gold Mines.
Famous people from Carmarthen:
Rhod Gilbert, Comedian and Philip Vaughan, inventor of the ball bearing