What regulatory agencies have audited QPS?
In 2000 EPA audited QPS-US for a series of FIFRA studies performed in 1997-2000. A 483-equilvant was issued with “No Finding”. In 2007 FDA audited QPS-US for a BE study performed in 2002-2004. Three of the four points on the 483 were focused on chromatography. At that time, QPS-US, like the rest of the industry, did not have a chromatography SOP. QPS had a draft version of that SOP before the FDA audit. FDA recognizes that although QPS did not have an effective SOP in place, the PI was consistently using the same integration parameters. The final point of the 483 was about documentation, which was addressed before the audit, as the documentation procedure during the 2002-2004 period was different than the current effective procedure.
