Good Distribution Practice – GDP
Any company who is procuring, storing, distributing or supplying medicinal product for wholesale distribution requires a Wholesale Distribution Authorisation WDA (H) issued by the MHRA (UK).
Our expert consultants are here to help you achieve full compliance, whether you are just setting out or have held an Authorisation for a while and need assistance with complying with the Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).
Offering advice and services relating to:
- Quality Systems
- Personnel, Contract RP Services, Training and Refresher Training
- Premises, including Temperature Mapping and Control
- Complaints, Recalls and Falsified Medicines
- Third Party Contracts and Outsourced Activities
- Audits, Self-Inspections and Pre-inspection Audits
Why Consider Us for GDP Consultancy?
Our Consultants and Contract RPs are registered with the MHRA and are able to offer a wide range of knowledge and experience to help you meet the requirements of GDP compliance and give ongoing support and advice.
Having assisted many organisations to successfully obtain and retain their Wholesale Distribution Authorisations, we offer a wide range of knowledge and experience in the requirements of Good Distribution Practice.
Our team have differing backgrounds and are carefully selected to ensure that the consultant’s skills, knowledge and understanding are the best fit for your business model.
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.
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
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!
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.
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
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.
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 DaviesDavies International Transport Limited
The day was fun and I enjoyed the review of GDP requirements!
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.
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.
Very informative. Was hesitant about attending but very happy I did. Jackie was excellent.