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...
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...
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,...
Essential Guide to MHRA GDP Audits & Inspections: Preparing for MHRA Compliance
GDP Audits & Inspections To Master GDP Audits conducted by the MHRA is to achieve a level of expertise and control that ensures seamless regulatory compliance and ensures patient safety, the ultimate goal of GDP activities! MHRA Inspections are critical...