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.
Top Tips for Effective Transport Validation
Effective Transport Validation: 10 Top Tips Following on from our blog post relating to the “Transport Validation Exercises: A GDP Compliant Approach”, and as there are several elements of performing effective transport validation exercises, we thought it may be beneficial to share some hints and...
Temperature Mapping Top Tips: Medicinal Product Storage Areas
Temperature Mapping: What the Regulations Say Chapter 3.2.1 of the EU GDP Guidelines dictates: “An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located in accordance with the...
Transport Validation Exercises: A GDP Compliant Approach
The Importance of Transport Validation Exercises: A GDP Compliant Approach In the pharmaceutical industry, patient safety is paramount. One critical element in ensuring that safety is maintained throughout the supply chain is the transport you use to deliver your medicinal products to your...
Audit Planning: Tips and Tricks
Tips for Audit Planning Whether you are performing a ‘First Party’ internal audit, otherwise known as a self-inspection, a ‘Second Party’ external audit, usually relating to a supplier or customer, or a ‘Third Party’ audit, audits performed by a regulator, accreditor or an independent auditor,...
1st and 2nd Party Audit Report and Follow-up
Producing an Audit Report: What Happens Next Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’ approach and in their eyes, if it’s...
2025 Pharma Industry Awards Finalist!
We're in the Pharma Industry Finals! We’re thrilled to announce that Paradigm Shift has once again been named a double finalist at the prestigious UK Pharma Industry Awards 2025! Our team’s dedication and commitment to GDP compliance have earned us recognition in two outstanding categories: ...
Essential Guide to MHRA GDP Audits & Inspections: Preparing for MHRA Compliance
Don’t let common GDP audit findings derail your compliance efforts. Discover proactive strategies to anticipate and address deficiencies before they become major issues. Learn how to transform potential pitfalls into compliance wins.
Good Distribution Practice (GDP) UK: Ensuring Pharmaceutical Quality & Safety
What is "Good Distribution Practice" and why does it matter for ensuring Pharmaceutical Quality and Safety? In the evolving world of the pharmaceutical supply chain, one crucial element often remains behind the scenes: Good Distribution Practice (GDP).While we readily acknowledge the importance of...
Counterfeit and Falsified Medicines – What Are They?
What Can We Do about Counterfeit and Falsified Medicines?Counterfeit and falsified medicines are a global problem that poses serious risks to public health and safety. They are products that are deliberately and fraudulently mislabelled with respect to their identity, composition, source or...
What is a Risk Assessment (RA) in GDP?
Risk Assessment is the process of finding, recognising and describing potential sources of harm within in the GDP supply chain.