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

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Strengthening your QMS with Quality Risk Management

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...
Standard Operating Procedures: A no-nonsense Guide

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?

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

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...
Understanding Controlled Drugs Licensing 2026

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...
Application for a Wholesale Distribution Authorisation in 2026

Application for a Wholesale Distribution Authorisation in 2026

The team at Paradigm Shift are often asked what the Wholesale Distribution Authorisation application process is. Whilst we have written about this subject in the past (Wholesale Dealers’ Application  and Wholesale Distribution Authorisation Explained), we...