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Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.
As Albert Einstein once wrote, “not everything that counts can be counted, and not everything that can be counted counts.” Current regulations seem to demand that instruments prove that a contaminant is not present, when all they can show is that it has not been detected. As the authors write, only strong validation, process control, quality management and training programs can help ensure that regulations are met or surpassed.
eBook: Biologics and Sterile Drug Manufacturing 2019
When referring to this article, please cite it as R. Madsen and J. Agalloco, “Unknown and Unknowable," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).