March 28, 2023 || Robert Chew, PE
Reviewing history of qualification practices in the biopharmaceutical industry, there has been constant tension between perceptions of regulatory requirements, application of good engineering practice, project delivery constraints (cost and schedule), and successful technology transfer resulting in high levels of process performance and reliability. In the late 1980’s and early 1990’s…
March 28, 2023 || Chip Bennett
Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in Commissioning, Qualification, and Validation projects? What are the risks of not performing Design…
March 28, 2023 || Jeff J. Gaerke P.E.
Executive Summary There has been significant debate over the years between regulatory agencies and the pharmaceutical industry regarding the advantages and disadvantages related to patient sterility risk with performing Pre-Use Post-Sterilization Integrity Testing (PUPSIT) of sterilizing-grade filters. This white paper will not add to this specific discussion; instead, the purpose…
