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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
Redhill is a town in Surrey, in the South East region of England. Redhill is located close to Reigate and approximately 20 miles south of Central London. Other towns and cities within easy reach of Redhill include Crawley which is 10 miles away, Guildford 25 miles, Horsham 20 miles and Sevenoaks 30 miles. Redhill is only 4 miles from the M25 and has mainline train services into London Victoria and London Bridge which makes it prime commuter land. London Gatwick airport is just over 6 miles away opening up easy access to international business and holiday travel. Although Redhill itself is not a particularly attractive town, it is surrounded by located is the picturesque Surrey countryside including the North Downs, a designated Area of Outstanding Natural Beauty, which offer great walking and cycling opportunities and numerous country pubs.
Famous people from Redhill include: Nick Hornby, writer (Fever Pitch, About a Boy and High Fidelity) and Chris Robshaw, former England rugby captain