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Pharmaceutical Technology

Pharmaceutical Technology-05-15-2019
Volume2019 eBook
Issue 1
Pages: 4­–9

Unknown and Unknowable

Author(s):

Russell Madsen,James P. Agalloco

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 Technology’s Biologics 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).

Articles in this issue
Supply Chain Challenges for Single-Use Systems
Supply Chain Challenges for Single-Use Systems
Challenges with Successful Commercialization of Biosimilars
Challenges with Successful Commercialization of Biosimilars
A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations
A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations
Test Methods and Quality Control for Prefilled Syringes
Test Methods and Quality Control for Prefilled Syringes
Unknown and Unknowable
Unknown and Unknowable
Distinguishing Between Cleanroom Classification and Monitoring
Distinguishing Between Cleanroom Classification and Monitoring
The Link Between Manufacturing and Commercialization in Gene and Cell Therapies
The Link Between Manufacturing and Commercialization in Gene and Cell Therapies

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