GXP Systems

Data Integrity project

Our customer, an internationally renowned multi purpose device and pharma contract manufacturer, had transferred a number of laboratory test methods from their former site based in UK to Ireland.

These methods are used to test manufactured Active Pharmaceutical Ingredients (APIs) in order to provide evidence that the manufactured products tested using these methods conform to established specifications for identity, purity and quality and comply with pharmacopeia and current Good Manufacturing (cGMP) requirements for pharmaceutical products for human use.

In this case study, you will learn about the steps we took to determine how effective their data integrity management structure was, and the recommendations that followed. 

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