Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Human Error is Not the Root Cause!
Strengthening Root Cause Analysis (RCA) in GDP At a time when the Medicines and Healthcare products Regulatory Agency (MHRA) continues to highlight deficiencies in deviation investigations, one thing is clear… effective root cause analysis is essential for compliance...
Why GDP Matters to Pharmaceutical Wholesalers
The Importance of GDP Guidelines from Manufacture to Wholesale The quality and safety of medicines depend not only on how they are manufactured, but also on how they are distributed throughout the supply chain by pharmaceutical wholesale distributors, and this is...
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...
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...