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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
Arundel is an historic town located in the South Downs National Park in West Sussex in the South East region of England. Arundel is approximately 49 miles from London, 18 from Brighton, 40 from Portsmouth and 10 from Chichester, the county town of West Sussex. Other towns within easy reach include the seaside resorts of Worthing, Littlehampton and Bognor Regis. Arundel lies on the River Arun and has many beautiful listed buildings including a castle, home to the Duke of Norfolk and a cathedral which dominate the skyline. Arundel’s location in the South Downs National Park makes it an ideal base for walkers, cyclists and wildlife watchers. There are also numerous individual shops, galleries, restaurants and pubs in the town and surrounding villages national park.
Although many Arundel residents commute to Brighton, London and elsewhere, a number of large companies do provide more local employment opportunities including the worldwide HQ of Body Shop in Littlehampton, Butlin’s holiday camp in Bognor Regis and Goodwood Race course which stages regular horse racing and motor racing events such as the Festival of Speed and Revival. Goodwood is also the home of a large Rolls Royce factory.