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.
Strengthening your QMS with Quality Risk Management
Integrating your Quality Risk Management into your QMS Quality Risk Management (QRM) is not just a "nice-to-have" in Good Distribution Practice (GDP), it is a minimum expectation rooted in National law, guidance, and best practice. When applied correctly within a GDP Quality Management System...
Why Management Reviews Are Important (2026)
Why Management Reviews are Important for Maintaining an Effective Pharmaceutical QMS In today’s highly regulated pharmaceutical environment, the integrity, reliability, and continual improvement of a Quality Management System (QMS) are fundamental to ensuring product quality and patient safety....
Managing Deviations with Confidence: Essential Insights into GDP Compliance
Confidence in GDP Deviation Control Ensuring adherence to Good Distribution Practice (GDP) is fundamental to maintaining product quality, legal compliance, and, ultimately, patient safety. When everyday activities on a licensed distribution site become complacent or shortcuts occur, the company...
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 world of Good Distribution...
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 the principles and requirements for...
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 Authorisation (WDA) must include...
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, software, implant, reagent, material...
What is classed as a Medicine in the UK? (2025 Edition)
What is classed as a medicine in the United Kingdom: A Practical Regulatory Guide for Pharmaceutical Wholesalers & Distributors Understanding this is fundamental for any organisation involved in the wholesale distribution, storage, or supply of medicinal products. The UK maintains one of the...
Understanding Controlled Drugs Licensing 2026
What Wholesalers & Wholesaling Pharmacies of Controlled Drugs Must Know Holders of a Wholesale Distribution Authorisation (WDA) must abide by a range of complex regulatory landscape. If you supply medicines, in particular, controlled drugs in Schedules 2-5, there are dual obligations you must...
Do Pharmacies Need a WDA? (2026)
What Pharmacies Need to Know Now About WDA(H): A Full Guide for 2026 Supply chains in pharmacies have tightened significantly since the days of the “5% rule.” If you’re a pharmacy owner, superintendent pharmacist, or part of a hospital or community pharmacy, it’s essential to know whether your...