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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
Maidenhead is a large town in the county of Berkshire in the South-East region of England approximately 30 miles from London, 13 from Reading and 32 from Oxford. Other major towns within easy reach of Maidenhead include Slough, Marlow, Henley on Thames and Windsor. Maidenhead enjoys excellent transport connections, being located on the A4 and M4 and having regular trains services into London which means that many residents commute into London, Slough, Reading and other towns.
The three main industries in Maidenhead and surrounding areas are pharmaceuticals & life science, visitor economy and digital technologies. Pharmaceutical and Life Science companies in the Maidenhead area include Abbvie, GSK and Johnson & Johnson, Abbott Laboratories, Biogen Idec, Covance, Inventiv Health, Sanofi Pasteur and Seqirus. Maidenhead lies on the “Silicon Corridor” which is home to numerous digital and other technology companies Telecommunications, Cyber Security, Data Centres and Cloud Computing, Big Data companies include Adobe, Hitachi, 3, LexMark and Fujitsu. The Royal Borough of Windsor and Maidenhead is home to many famous attractions including Windsor Castle, Legoland, Royal Ascot and Eton College. It also boasts many high-quality hotels and four restaurants with 3 Michelin stars. As a result, the visitor economy is a major employer in the area.
Famous people from Maidenhead: Geraldine James, actress and Hugh Lofting, author and creator of Dr Dolittle.