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.
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.
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
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!
Pharmacy Consulting have provided our business with excellent support, advice and training with regard to obtaining Wholesale Dealers Authorisation following the implementation of European Commission Guidelines of 5 November 2013 on Good Distribution Practice, 2013/C 343/01. I would like to personally thank Dawn and her team for her personal assistance in securing the authorisation.
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.
Pharmacy Consulting provided us with a very professional and efficient service over a number of extremely busy months. Not only were they flexible to our requirements but also to our workloads, time schedules and finances. Jackie Peck in particular was extremely aware of our needs and outcome requirements. For a small company such as ourselves this was invaluable. At all times Pharmacy Consulting kept us informed of any amendments, changes, monetary matters and as the client we felt it was a very professional service. The intended outcome was successfully achieved and the team at Pharmacy Consulting went above and beyond their duties as consultants for us. I cannot recommend them enough.
Pharmacy Consulting has been performing consultancy work for Vygon for several years, during that time they have provided us with a very professional and efficient service. PCL helped Vygon obtain their original Wholesale Dealers Licence and have provided Responsible Person (RP) support to our Quality Team ever since. PCL guided us successfully through our MHRA inspection. More recently, Jackie delivered GDP update training sessions for me and my deputy when I started in my new role as Head of QA/RA. I would recommend PCL to any organisation that needs support in their pharmaceutical operations. Vicky MuirQA/RA ManagerVygon