What happens when Product is delivered before Release?

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

A pharmaceutical company in the US shipped an over-the counter (OTC) drug product three days before receiving the certificate of analysis (COA) from their contract laboratory. This COA included assay results for the active ingredient. Furthermore, batch records had not been reviewed. However the company told the customer that the batch was released.

The company also repacks and relabels APIs. Here, the company "failed to ensure that records are maintained and reviewed for each API that is relabeled". In fact the company did not have a procedure for relabeling APIs. Furthermore, the company "failed to adequately review re-packaging batch records before release".

This all was discovered in an inspection by the US Food and Drug Administration (FDA) and led to a Warning Letter. What makes it even worse is the fact that in a previous inspection three years ago, the company was "also cited for not having appropriate procedures in place" for its operations".

Besides the Warning Letter, the FDA may also "withhold approval of requests for export certificates and approval of pending new drug applications or supplements" listing this facility as a supplier or manufacturer "until the above violations and deviations are corrected".