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.
Lots of information and keeps you engaged.Isatec on site training – Abbey Tullett
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
I have really enjoyed the training. Zul is a very good communicator and very approachable. 🙂
The day was fun and I enjoyed the review of GDP requirements!
Very useful day with a good overview of MHRA GMP & GDP process, procedures and roles and responsibilities.Isatec on site training – Andrew King
A lot of valuable information to digest.Thank youAnna Drys – Oxford Hospital
Well structured and presented course. Puveshni was very knowledgeable in the field and benefited from her experience.Abdirahamn Sheikh – Irmaan
Very interesting presentation which allowed me to gain a proper overview of the GDP process.Isatec on site training – Jack Shock
Very informative. Thank you.
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.