Unknown and Unknowable

May 15, 2019
Russell Madsen

,
James P. Agalloco

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2019, Volume 2019 eBook, Issue 1
Page Number: 4­–9

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.

Read this article in Pharmaceutical TechnologyBiologics and Sterile Drug Manufacturing 2019 eBook.

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 4–9

Citation

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).