Responsible Person (RP)
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 a Responsible Person
- 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
Scotland
Scotland is a country that is part of the United Kingdom. Covering the northern third of the island of Great Britain.
The global cell and gene therapy market was valued at $6.68 billion in 2019 and is expected to reach $13.23 billion in 2023 at a CAGR of 24.10% (Ref. BusinessWire).Also in 2019, a joint report from The Alliance for Regenerative Medicine (ARM) and the BioIndustry Association (BIA) stated that the UK is a leading source of innovation and development of advanced therapy medicinal products (ATMPs) in Europe. These products, which include gene therapies, cell therapies, and tissue-engineered products, are intended to augment, repair, replace, or regenerate organs, tissues, cells, genes, and metabolic processes within the body. Scotland has a strong reputation in research & translational development in these fields and is rapidly growing a vibrant cluster of spin-out therapeutic companies, increasing clinical trials of new Advanced Therapy Medicinal Products (ATMPs) as well as expanding its manufacturing capability.
Scotland also has established expertise in developing and manufacturinghuman vaccines(the global market projected to grow to $96b by 2023 according to Business Research Company) and animal vaccines (worth $9b by 2025 – Global Market Insights, Inc).
Scotland’s profile and contribution towards the growth of the UK ATMP sector is increasing rapidly. A strengthening supply chain is supporting new advanced therapy applications – fuelled by world-leading academic expertise in cell & gene therapy and regenerative medicine,. With a forward focus on translation, specialised clinical trials, and GMP manufacture and analysis, Scotland is growing a vibrant infrastructure to support end-to-end development of advanced therapies.
Human and animal vaccine development is a strength in Scotland represented by companies such as Valneva, Neogen, and GalvMed as well as the Moredun Research Institute. In addition to Valneva’s Covid-19 Vaccine programme, Scotland’s supply chain made huge contributions to the development of Covid-19 vaccines including Merck BioReliance, Charles River, Symbiosis, SGS, Ingenza & ReproCell Europe.
One of the largest life sciences clusters in Europe, Scotland is home to a range of multinationals and small and medium enterprises (SMEs) with a strong track record of creating and growing startups.
Scotland has comprehensive supply chains and world class manufacturing expertise supplying chemical and healthcare equipment, pharmaceutical services, medicines, vaccines and diagnostics to the world.
The cluster continues its rapid expansion building on a strong industry base, leading universities with a thriving entrepreneurial culture and close collaborations across industry, academia, the National Health Service and government.
Scotland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Scotland, scientific careers in Scotland or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Scotland, give our Next Phase team a call. The Scottish area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in Scotland, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the Scottish area.
