The Need for Responsible Person (RP) Support
GDP Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) stipulate the requirement of the Responsible Person (RP) as well as their duties and obligations expected of them by undertaking this role. The RP must have a high level of knowledge, demonstrate competence and deploy the right skills so that patients and healthcare professionals have the confidence and trust to use medicines.
Pharmacy Consulting Limited has been offering services to new UK Wholesale Distributors of Medicines since 2006.
We offer various levels of services:
- Supporting Wholesalers New and Old to obtain their WDA and processes required within the application
- Building Quality Systems in compliance with GDP as evidenced by many MHRA Inspections
- Acting as an external support network for an internal RP
- Acting on an ongoing basis as a contract RP
- Training for new wholesalers
- Update training for your Continuous Professional Development
Our strength is to develop a project plan bespoke to the client and their business needs, allowing us to collaborate together to achieve the end goal of maintaining a compliant wholesaling business with a WDA.
Why Consider Us for a Contract RP?
With extensive experience acting as RP for a number of businesses, you can be assured that we will provide up-to-date advice, a necessary service level and compliance with the MHRA regulations. We live and breathe the pharmaceutical market and just a short telephone conversation with us will help to demonstrate the depths of our expertise.
Any WDA (H) needs an authorised RP by the competent authority, MHRA (Medicines and Healthcare Products Regulatory Agency).
Jackie Peck, John Finey and Azul Mamon are our active RPs for several companies across the UK. Our consultants are approved by the MHRA to act as a Responsible Person for UK Wholesale Distributors of Medicines and we have supported and still support a number of new market entrants to the UK wholesale pharmaceutical market.
They work to prepare and submit applications to achieve a WDA. Our RPs works to develop a Quality System to cover the wholesaling of medicines in compliance with Good Distribution Practice as evidenced by successful MHRA Inspections.
For further information contact us.
We also offer GDP/RP Training courses.
Please click on the links below to view full details of each case study.
I found the course on Training to be a responsible person to be a very well thought and structured course which gave me the roles and resources to come away understanding the training given. It was very informative, topical and saved me time and money trying to wade through a minefield of work to become a responsible person – Jackie is highly qualified and delivers an excellent course, would highly recommend to anyone looking at wholesaling.
‘Really clear and concise and very helpful to point out how much work is still required of us. A great start to the RP journey.’Jon Barden
Just wanted to say thank you for the training last week, was education and fun, and it was great to be able to spend time with a professional auditor.
Dawn ran a very informative session about GDP guidance and the role of the Responsible Person. This helped me understand further about my role as the Responsible Person and how to stay 100% compliant according to the guidelines. I also picked up key points on what to look for when looking at potential suppliers and warehouse facilities. All together an excellent session, worth every penny! Pharmaceutical Wholesaler Client
“Very Informative. Great handouts to take away. Thanks”Megan – Course Rating 10/10
“Great Presentation, very informative.”Roshni Rutton-Patel – Course Rating 10/10
I want to thank you again for your successful presentation made in London to our Pharma Group Europe conference.Your detailed explanations for all the delegates were extremely interesting and enlightening.Our international participants from Germany, Austria, Switzerland and Romania expressed their praise and encouragement. Zdenek Schmittz- Pharma Group Europe
We loved your training at Niche!
Good knowledge and practical insight into the requirements.
” Very fun, interactive course. Trainer was very approachable.”Farhan Masoud – Course Rating 9/10