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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
Sandwich is a town in the east of Kent in the South East region of England. Other towns and cities close to Sandwich include Canterbury, Ashford, Dover, Ramsgate and the revitalised resort town of Margate. The name of the town is probably of Saxon derivation meaning a “sandy place” rather than the well-known lunchtime food item. It is thought that the term “sandwich” came about when the 4th Earl of Sandwich asked for his lunchtime meat to be served between slices of bread so that he did not have to interrupt his gambling for lunch! Sandwich was one of the Cinque Ports which was a confederation maritime towns and villages in Kent and East Sussex dating back 1000 years that supplied fleet, military and transport services to the Monarchy prior to the creation of the Royal Navy. Although it was a major port in bygone days, Sandwich is now two miles from the sea and the reclaimed land is home to nature reserves and golf courses including Royal St George’s.
Pfizer, the multinational pharmaceuticals company, is a major employer in Sandwich and many well-known drugs including Viagra were developed in their laboratories in Sandwich. In addition to Pfizer, Discovery Park in Sandwich, the leading science park in Kent, is home to numerous Life Science, Biotech, Technology and R & D companies which employ a total of 3000 staff.