Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Blog
Take a look through our free blogs that cover a number of different areas of Good Distribution Practice (GDP). Each blog addresses primary topics including training, inspections and procedures. If you need any more information or any assistance/training don’t hesitate to contact us by email or phone.
Wholesale SOPs
Your Wholesale SOPs are the backbone of your QMS… but what are they?
Wholesale Dealer Licence Application
Do you know what is required for a Wholesale Dealer Licence Application?
Gold Standard – Responsible Person, Medicinal Products
The Gold Standard for RPs (medicinal products) was released in June 2014.
An Inspector Calls
During an MHRA Inspection an Inspector will be looking for evidence of GDP compliance throughout the company.
Cogent SSC Announce Gold Standard for RPs
Cogent SSC Gold Standard for RPs. Talking of this development, Mark Birse, Group Manager GMDP Inspections at MHRA commented “Responsible Persons play a vital part in ensuring the quality and the integrity of medicinal products are maintained throughout the distribution chain. It’s essential...
Good Distribution Practice Training / GDP Training
GDP Training is a requirement for all personnel involved in wholesale distribution of medicinal products. We run monthly courses.
National Competent Authorities
Who are the National Competent Authorities for each country in Europe?
Do you know what you are doing?
You may be surprised at the number of enquiries we receive from prospective clients who want to get a WDA (H) (wholesale dealer authorisation for medicines for human use) and start what they think is an "easy" business. Everyone needs drugs, right? A safe investment for the future is medication...
Don’t want to buy the Green Guide? Download the European Guidance on GDP for free
The Green Guide is an extremely useful compliance tool, containing further detail on what is included in the EU Guidance 2013.
Eudra GMDP database – European Medicines Agency
Eudra GMDP is the database used by the European Medicines Agency. It is an important tool for bona fide checks.