Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Standard Operating Procedures: A no-nonsense Guide
Standard Operating Procedures: The Skeleton of your Licenced Operation If your Quality Management System (QMS) were a house, Standard Operating Procedures (SOPs) would be the joists, hidden from view by design, but essential to keeping everything standing up. In the...
What Are the Main Elements of GDP Guidelines in 2026?
GDP Guidelines: The Main Elements The GDP guidelines (Good Distribution Practice) for medicinal products consist of ten working chapters and two annexes, which cover the following topics: Chapter 1 – Quality Management We start the GDP guidelines with describing...
GN14 Explained: What Pharma Wholesale Distributors Need To Know
Unlicensed Medicines: Key Guidance Note 14 (GN14) requirements for wholesale distributors When a pharmaceutical wholesaler becomes involved in the sale and supply of unlicensed medicines, often referred to as “Specials”, the scope of their Wholesale Distributors...
What Is A Medical Device?
What Are Medical Devices? Medical devices cover a broad and varied range of products that are intended for medical use in human beings. In the UK context (and derived from international definitions) a “medical device” means any instrument, apparatus, appliance,...