Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
ALCOA++ and the Future of Data Integrity in GDP
Why ALCOA++ Matters in Good Documentation Practices (GDP) In the pharmaceutical supply chain, documentation is more than just paperwork, it is the core of product quality, patient safety, and regulatory compliance.As we move further into an era of digital records and...
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...
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...
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...