As the pharmaceutical industry has grown up, a complex system of safety and quality assurance has evolved around it. However, new issues arise each year that challenge product quality and supply chain security and require additional quality systems to be added.
The globalisation of the pharmaceuticals market is probably the key factor influencing quality issues at the moment. Through its long-established and accountable regulatory authorities, Western governments have demanded ever more stringent processes based on the foundation of Good Manufacturing Practice (GMP). The goal has been to get companies proactively to identify and promptly correct issues and manage facilities and change through the implementation of robust quality management systems.
This worked well while Western drug manufacturers were able to recoup the costs through sufficient reimbursement of products and while all those involved were working to similar standards. However, today’s market has changed unrecognisably in terms of geographical spread. It is now populated by global players with varying levels of competency, manufacturing infrastructure, regulation and supply chain security. Issues of quality, adulteration and ‘passing off’ have risen in that time.
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