Paul Mason, PhD, Lachman Consultants, wrote a recent article for Contract Pharma discussing why it is critical to have controls in place during out-of-specification investigations to provide quality assurance.
Here is a brief excerpt from the article: “While being audited by government health agencies, it can be expected that quality investigations will be reviewed since the investigator is going to determine if the appropriate/correct decisions are being made by the firm’s quality unit when “things are not going to plan!” This is particularly the case during Out-of-Specification (OOS) investigations when batches of material of considerable value cannot be released due to an outstanding investigation. The investigator is aware of the risk of closing the investigation by conveniently assigning the root cause to the laboratory—and thus by, de facto, assuming the OOS does not reflect material quality concerns—to justify the release of the batch.”
