Registered Office: Paradigm Shift Consulting Ltd,The Old Mill, 9 Soar Lane,Leicester, LE3 5DE, United Kingdom

Paradigm Shift Consulting Logo

0330 133 0920

Paradigm Shift Consulting Logo
What Are the Main Elements of GDP Guidelines in 2026?

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...
What is classed as a Medicine in the UK? (2025 Edition)

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....
Wholesale Distribution Authorisation (WDA) Explained for 2026

Wholesale Distribution Authorisation (WDA) Explained for 2026

What is a Wholesale Distribution Authorisation (WDA)? Being in possession of a Wholesale Distribution Authorisation (WDA) – the terminology in the EU 2013/C 343/01 guideline – is a legal requirement for any company involved in the procurement, storage, or...
How to Navigate Medicine Classifications (2026 edition)

How to Navigate Medicine Classifications (2026 edition)

Navigating Medicine Classifications, GDP Guidelines and WDA Scope. For pharmaceutical distributors, the moment a product is determined to be a medicinal product, the regulatory landscape changes. Licence obligations, handling, supply chain and recipient eligibility...
Human Error is Not the Root Cause!

Human Error is Not the Root Cause!

Strengthening Root Cause Analysis (RCA) in GDP At a time when the Medicines and Healthcare products Regulatory Agency (MHRA) continues to highlight deficiencies in deviation investigations, one thing is clear… effective root cause analysis is essential for compliance...