Lack of Supplier Qualification leads to Recall

Recommendation

4/5 November 2020

Live Online Training: The GMP-Compliance Manager

The company Hospira Deutschland GmbH had to recall vials of their antibiotic drug Meropenem. The main reason for this was that a supplier of an important raw material was not qualified. As a result, this manufacturer was not listed in the respective authorisation and the batches affected did not correspond with the authorisation documents. According to a press release issued by Hospira GmbH (German text), the medical evaluation stated that "the risk of adverse events occurring as a result of this are to be considered low. There is currently no indication that patient safety was affected by the quality or efficacy."

Nevertheless, this example shows the negative and unpleasant consequences for companies and patients if suppliers are not or are inadequately qualified. A change notification for the supplier to be included in the authorisation documentation is currently in progress.