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 (née Heneghan) 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.
We also offer GDP/RP Training courses.
Please click on the links below to view full details of each case study.
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
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 interesting presentation which allowed me to gain a proper overview of the GDP process”Jack – Course Rating 9/10
“A really useful day.”Martin – Course Rating 10/10
Pharmacy consulting helped us to map our warehouse and also to map our new pharmacy fridge they were much cheaper that the other quotes we had and they also trained up the staff on the cold chain SOPs we had jointly written. Thank you Jackie for all your help!
“Very informative and lots of opportunity to ask questions and speak with other people on the course.”Megan – Course Rating 10/10
“Very Informative and useful session”Rahinatu – Course Rating 10/10
Since 2012 we have been using PCL for regulatory support, staff resourcing, training and general advice. We have consistently found that the whole team has a high level of technical competence, are always willing to get stuck in to help us and are able to come up with robust ideas to improve our systems. I would have no hesitation in recommending their services in any of these areas.
“MHRA GDP guidelines are numerous and specific and potentially serious if not followed. The training went through each point in a common sense way, so the guidelines have appeared far more admirable and attainable.”Philip Hodgkinson – Course Rating 10/10
“Nice Chap, explained everything in an easy to understand manner!”Andrew Kruinlger – Course Rating 10/10