Who can be a Responsible Person (RP)?

by | Sep 29, 2017 | Blog, Consultancy, GDP/RP, Good Distribution Practice - GDP, MHRA, RP, Training

The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person (RP) for GDP. The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices.

According to the guideline “RP should meet the qualifications and conditions provided”. In the UK this means the RP should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas, sites, stores and records which relate to the licensable activities and regularly monitor and review all those areas. Qualification requirements is not as strict as in other countries, pharmacy degree is desirable but not necessary as long as the RP can demonstrate at least 1 year experience in medicinal products distribution.

PCL  organising a monthly training course on (GDP) Good Distribution Practices (full day) for new/existing RP or team members to learn about the requirements, also RPs can attend RP refresher (half day) courses where they can learn more about role and responsibilities of the RP and can get latest feedbacks from inspections and MHRA requirements .

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As a busy family run logistics business we are really grateful for the expertise of Pharmacy Consulting who came alongside us, pulling out all the stops to meet tight deadlines and helping us to elevate the standard of our Quality System.  Thanks to the assistance of Jackie and her team, we are now able to satisfy the exacting standards of larger pharmaceutical wholesalers thereby improving our offerings to our clients and opening up new avenues for our business in the future.   Steven Dav… Read more
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