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.
The day was fun and I enjoyed the review of GDP requirements!
Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.Isatec on site training – Bill Castle
Very interesting presentation which allowed me to gain a proper overview of the GDP process.Isatec on site training – Jack Shock
I have really enjoyed the training. Zul is a very good communicator and very approachable. 🙂
A lot of valuable information to digest.Thank youAnna Drys – Oxford Hospital
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.
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.
Lots of information and keeps you engaged.Isatec on site training – Abbey Tullett
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.