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.
UK Pharma Industry Awards Winners 2025
Paradigm Shift Consulting Wins the Pharma Industry Awards UK 2025 – Pharma Education and Training AwardWe are beyond thrilled to share that Paradigm Shift Consulting Ltd, has won the Pharma Education and Training Award at the Pharma Industry Awards UK 2025 for the cost-effective training on their...
Why Staying Up to Speed with GDP Matters
Introduction The GDP pharmaceutical supply chain is one of the most tightly regulated sectors in the UK and across Europe, and for good reason.Medicinal products are not like other consumer products. They are extremely sensitive products; any compromise in their quality, safety or efficacy can...
Closing Meetings: What to expect from the MHRA Inspector
A closing meeting overview following an MHRA GDP Inspection A closing meeting following a third party, MHRA (Medicines and Healthcare products Regulatory Agency) audit, most commonly referred to as an inspection, is a critical part of the inspection process. It serves as a formal opportunity for...
MHRA Inspection: Are You Ready?
Being ready for the MHRA inspector Does your organisation go into panic mode the second you receive notification from the MHRA that they are coming to perform an inspection on your quality systems? Do your quality team frantically start pulling 5 years’ worth of documents from your archive area? ...
External (2nd Party) Audits: Their Importance
External (2nd Party) Audits If you’re a UK wholesale distributor of medicinal products, maintaining compliance with Good Distribution Practice (GDP) is not just a regulatory obligation, it is a core part of safeguarding patient safety and product integrity. GDP guidelines, issued by the European...
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...