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.
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.
The EU MDR and ISO 13485: Are you compliant?
ISO 13485 and your Quality Management SystemThe European Union Medical Device Regulation (EU MDR) is a new set of rules that came into force on May 26, 2021, replacing the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). The EU MDR aims to improve...
Cold Chain Storage of Medicinal Products
Cold Chain is the process of maintaining the quality and integrity of medicines that require lower than ambient temperatures in storage and transportation.
Documentation to GDP Compliance
Documentation is an essential part of GDP, as it provides evidence of the actions taken by the distributor to demonstrate compliance with the applicable regulations and guidelines. It also facilitates traceability of the distribution process, enables effective recall of defective products, and supports continuous improvement of the quality system.
What is Change Control in Good Distribution Practice (GDP?
Change control in GDP is a process used to manage any changes that may affect the compliance with Good Distribution Practice. GDP is a set of guidelines that ensure that medicinal products are stored, transported and handled under suitable conditions, as required by the marketing authorisation or product specification.
What is a QMS (Quality Management System)?
In the pharmaceutical industry, a QMS is essential to comply with the regulatory requirements and standards for the manufacture, distribution, and supply of medicinal products. It covers all aspects of the pharmaceutical supply chain, from the sourcing of raw materials to the delivery of finished products to the end users.