Q3 2014 Who guards the guardians?

Corporate audits required our attention this quarter or, to be more precise, the remediation of findings noted by corporate auditors.  Time and time again we get surprised by how high the level is raised by corporate auditors as compared to governmental Inspectorate auditors as we once more  noticed in two global companies this quarter. You would expect a quality level accepted by an Inspectorate to be equally acceptable to corporate auditors but this assumption gets falsified on each occasion.  This raises the question who is checking on who, or as the Romans did put it “Quis custodiet ipsos custodies” i.e. who guards the guardians?

Guarding guardians apparently does not work in the pharmaceutical industry but the guarding of temperature profiles does. Since the introduction of the new Good Distribution Practices the monitoring of transport  temperatures has become mandatory not only for chold chain medicinal products but also for ambient products which formerly usually escaped attention. This quarter we supported a major  supplier of truck temperature control  devices  with the set-up of a qualification system which can help their customers to comply with these new regulations for their trucks and carriers.
While this certainly is future “stuff”,  echo’s from the past also keep hunting us as we got a request to write a clinical overview for an antimicrobial pharmaceutical product launched in 1957. We used to deliver this kind of document, formerly known as “expert report”, to various clients in the past quite frequently but over the last years this part of our services seemed to have been taken over by our Indian and East-European competitors. But not this one, which took us again through the fascinating clinical literature of the sixties when the expectations for pharmaceuticals still were very  high. This era was described by one recent investigator as “an era of incredible enthusiasm and belief in the future, hard to believe for contemporary clinicians…..”.  And this sentence was written even before the Ebola-crisis struck us, leaving these clinicians without a single effective medicinal product.