Quality is Not a “Four Walls” Problem: Inadequate Contractor QA/QC Drives $100 Million Damages Claim

Ensuring patient safety and preventing problems with FDA aren't the only reasons why pharma companies should be meticulous about QA and QC .  But quality doesn't only mean the QA and QC that occur within a company's four walls but what happens at contract partner's facilities as well. Due diligence, both within and outside the "four walls," can prevent litigation as well. Consider this recent case from the "Show Me" state involving POSILAC bovine somatotropin, the controversial hormone used to increase cows' output of milk. Monsanto has sued Sandoz over inadequate Quality operations at its site in Kundl, Austria, which manufactured API and handled some filling and finishing of Monsanto's POSILAC bovine somatotropin.  FDA had issued a warning letter to the site in 2003, citing, among other things, failure to understand the root cause of batch failures and failure to adequately control sources of microbial contamination. Sandoz reportedly addressed the problems and product quality was fine, but making improvements to the facility necessitated shutdowns and limited manufacturing capacity, causing Monsanto to fall behind in its contractual obligations. Presumably, Sandoz has incorporated whatever quality lessons were learned from this case in the past into the manufacturing of its followon biologic, Omnitrope, also made at Kundl. (An aside - The hormone increases milk production so effectively that it reportedly causes mastitis in the poor cows receiving it, and, although it has been acknowledged as being safe for humans, is not approved for use in Canada or the European Union for animal health reasons. There have also been some questions raised about the fact that it increases levels of insulin grown factor in cows. Concerns about impacts on human health have been unsubstantiated.  So far, a number of retailers in the U.S. claim to have stopped supplying milk from cows treated with the hormoneAnd I'll take my coffee black, thank you.) AMS