Correcting a Lack of Temperature Monitoring and Documented Temperature Excursions
Client: European Based Pharmaceutical
Project Scope: Single Incident
Unique Factors: Data Loggers
A client’s warehouse staff forgot to include data loggers within the packaging of the product. The oversight was discovered at the consignee’s site (China), which prevented the release of the product.
Data loggers are important because they provide the data required by industry, federal and international regulators in the event of an audit, or for the verification and release of a product into a market. At the moment raw materials reach their final destination, it’s crucial to ensure factors such as temperature remain within acceptable limits.
Upon review of the temperature data collected, LifeConEx supported a detailed investigation, consolidating all data collected and associated comments obtained during the transit of the product.
Using LifeConEx’s documentation, the client was able to provide validation of temperature and compliance, resulting in the release of the product into the market.