Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
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,...
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’...
Cold Chain Storage of Medicinal Products
Cold Chain Storage of Medicinal Products in Wholesale Cold chain storage is the process of maintaining the quality and integrity of medicinal products that require lower than ambient temperatures throughout the supply chain. This includes the storage and...
Documentation to GDP Compliance
GDP Compliance in Documentation 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. Documentation also facilitates traceability of the...