Russell Madsen

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.

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 

Articles

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.

Unknown and Unknowable

Cleanroom monitoring and classification are vital to operations but are still separate functions. This article discusses the differences between the two concepts and emphasizes the need for the two to remain independent. As they write, “A one-size-fits-all approach to cleanroom monitoring will not reflect the diversity of practices” within the industry. In addition, they write, classification values should not be used as monitoring targets.

	When referring to this article, please cite it as J. Agalloco, R. Madsen, and J. Akers, “Distinguishing Between Cleanroom Classification and Monitoring," 

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

Distinguishing Between Cleanroom Classification and Monitoring

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient. 