Problems with existing medicines

When this happens you need to:

• Define the problem;
• Inform the regulator;
• Conduct an urgent risk assessment to determine any impact on the consumer;
• Consider whether a recall is warranted and to what level (e.g. consumer level, retail level);
• Undertake a thorough root cause analysis with corrective action to ensure the problem does not recur.

All of these actions need to taken quickly, be properly documented and, if necessary, backed up with references from the scientific literature. This information needs to be available for review by the regulator at any time.

Our team has extensive knowledge and experience in risk assessment, quality assurance, manufacturing and GMP. We can help you respond to quality problems quickly and effectively to minimise the impact on your business.

Contact us for more information.



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