Avoiding Product Recalls and Losses Using Metrology & Statistics

In a GxP environment, products exposed to environmental conditions outside their tolerance – such as minimum and maximum temperature requirements – can lead to product recalls or losses. This webinar presents two case studies of how product recalls or losses were avoided using concepts from the field of metrology – the science of measurement – and statistics. The first case study explores how a 3PL distributing temperature-sensitive drugs (2°C-8°C) faced a product disposal decision due to apparent temperature excursions above the 8°C threshold.

Using concepts from the field of metrology, the 3PL avoided product losses by demonstrating the high probability that the temperature actually remained within tolerance. The second case study explores how a Medical Device manufacturer faced a product recall decision due to apparent exposure to out-of-tolerance relative humidity conditions. Using statistical tools, the manufacturer avoided the product recall by demonstrating that a measurement error caused the apparent non-conforming condition.
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