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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 an RP
- 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
Dunfermline is the second largest town in Fife, Scotland and is located approximately 3 miles from the northern shore of the Firth of Forth, 40 miles from Glasgow, 17 from Edinburgh and also 17 from Stirling. Dunfermline was the capital of Scotland for over 500 years. Dunfermline Abbey, which was founded in the 12th century by Queen Margaret, is the most famous ancient building in the town and its graveyard was been the burial place of 11 of Scotland's kings and queens up to including Robert The Bruce in 1329. Other ancient buildings include the Royal Palace, Abbot House and St Margaret's Cave.
There are numerous golf course within easy reach of Dunfermline, including the world famous St Andrew’s golf course which is only 40 miles away. The majority of employment in Dunfermline is in the service sector, with significant employers Sky UK, Amazon and Best Western. The Carnegie campus just outside the city is home to a growing number of technology, medical device and other hi-tech companies.
Famous people born in Dunfermline: Iain Banks, novelist and Barbara Dickson, singer/songwriter