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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
Rustington is a large village on the south coast of England close to the resort of Littlehampton in West Sussex. Major towns with cities within easy reach of Rustington include Chichester which is 15 miles away, Brighton 20 miles and Chichester, the county town of West Sussex, is 15 miles away. Rustington is a mixture of old and new, from the thatched cottages to modern buildings including shops, sports centres and a golf centre with an 18 hole course.
Although many Rustington residents commute to Brighton, London and elsewhere to work, 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, Goodwood Race and the Rolls Royce factory also in Goodwood.