No Documentation in the Inspection? Not a good Idea!

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

A quite interesting kind of inspection management has been developed by a company in China. It tries to work almost without any GMP documentation. Documents are then created for the purpose of a GMP inspection. The US health authority FDA has clarified in a Warning Letter that this does not really work. Several documents were created solely for the inspection, which the FDA interprets as a falsification. Among others, cleaning validation reports, batch records and the APR (Annual Product Review) were falsified. Furthermore no documentation could be provided e.g. for equipment qualification, raw material qualification and API testing, process validation and the stability program. No wonder that the topic of data integrity was also criticised.

All this led not only to the Warning Letter mentioned above, but also to the recall of products on the US market and the imposition of an Import Alert.