Article | October 2, 2018

The Evolution Of Validation In Pharma And Biopharma

Source: Bosch Packaging Technology

by Andrey Yermakovich, Validation and Quality Supervisor, Bosch Packaging Technology Pharma North America


Only a few decades ago, in the pharmaceutical industry, it was an acceptable practice to verify packaging machinery only by observing equipment run and checking basic functions. Since the 70’s, the industry has gone through a major change. Many regulations, standards, and guidelines that govern CQV (Commissioning, Qualification and Validation) practices were put in place. With that said, the commensurate level of adaptation was required. Major changes occurred again in 00’s. In the new era, it has to be demonstrated that all risks are mitigated, machines and processes are fit for intended use, and software and all functions operate as designed in a predictable and repeatable manner. To help the industry, Bosch began offering a full array of CQV solutions for new and existing machines or lines. In this article we will discuss how the industry changed, and how Bosch Packaging Technology adapted to the new business environment.