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 .

Testimonials

Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
API and Clinical Trails Training