Quality assurance provides confidence that quality requirements will be fulfilled. This benefits an organisation both internally and externally with increased productivity, regulatory compliance, reduced wastage, and reducing risks of costs as a result of service failure.

In pharmaceuticals, the cost at stake is much higher. Not only is it far more difficult to determine the solution to the problem following a quality lapse — namely the decision to administer, reengineer or remanufacture the drug in question, but due to the numbers of stakeholders and processes involved, numerous additional costs accrue along the way.

Consider these statistics in 2019:

The biopharma industry lost approximately $35 billion annually as a result of failures in temperature-controlled logistics, according to IQVIA Institute for Human Data Science. This figure includes

• lost product


• clinical trial loss and replacement costs


• wasted logistics costs


• costs of root-cause analysis