Rules for Investigating Good Manufacturing Practice (GMP) Deviations in Sterile Processing
23 May 2017
When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to det...
The Costs of Over-Complexity
16 May 2017
In this whitepaper, Martin Lush discusses the issue of over-complexity in the pharmaceutical industry.
Want to Change Your Quality Culture?
30 Mar 2017
Despite lots of effort, most change initiatives fail because behaviour of the masses remains unchanged.
Changing GMP Behaviours
18 Oct 2016
Most people are content to stick to tried and tested habits because it's easy. To encourage them to think and act in a new way (a difficult process for most), you have to provide motivation.
Human Reliability Improvement: How to Reduce Documentation Errors
26 May 2016
We live in a world where we are surrounded by electronic data transmitting to every device imaginable yet we continue to experience documentation errors.
Getting to the Bottom of Data Integrity
26 May 2016
Data integrity is a global issue and is not new. Integrity problems have been around for years and are not restricted to QC labs.
28 Mar 2016
Quality system elements have been in the top ten categories of deficiencies found in the UK by the MHRA for the last ten years.
The Importance of COPQ for the Pharmaceutical Industry
22 Mar 2016
As any senior executive within an organisation knows, the reduction of waste and, more importantly, the cost associated with that waste can have a major effect on any business.