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.
Manufacturers – Are you operating without a WDA(H)?
Manufacturers do not need a WDA if they are distributing their OWN products, but many are operating illegally by procuring and supplying, etc.
Quality Management Systems
An Quality Management System is a requirement for GDP compliance. Has yours been effectively implemented?
Broker? Yes or no?
Are you a broker? Do you understand how to be compliant with GDP guidelines?
Wholesale SOPs – Standard Operating Procedures
Your Standard Operating Procedures (SOPs) are a crucial part of your QMS and GDP compliance. Are yours effectice?
MHRA – Drug Recalls
You should be signed up to drug recalls alerts from the MHRA and be familiar with the classifications.
Registering as a Broker of Pharmaceutical Products
The 2013 EU GDP Guidelines mean that there is a requirement for the registration of brokers when dealing with pharmaceutical products.
Falsified Medicines Directive – A Pharmacists perspective – by Sultan “Sid” Dajani of the RPS
With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt of the changes in the continual pursuit of patient safety. Sultan “Sid” Dajani, Chairman of the Falsified Medicines Directive at the Royal Pharmaceutical Society, and UK...
MHRA Website relocation to .gov.uk
The MHRA website was relocated to GOV.UK
Bona Fides (Approval of Suppliers and Customers) Checks – how and why?
Are your suppliers and customers validated or bona fide? genuine; real. "she was a bona fide expert". Synonyms: authentic, genuine, real, true, actual, sterling, sound, legitimate, lawful, valid, unadulterated, legal, unalloyed, proper, straight, fair and square. Bona fides checks are a critical...
GDP Risk Management
Your Quality Management System needs to include detailed procedures on risk management throughout your operations/activities.