Cover: For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and has been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the 2020 ISPE Aseptic Conference.
Feature: The latest ICH guideline, ICH Q12, introduces regulatory mechanisms, such as established conditions (ECs), to simplify and expedite postapproval product variations and enable continual product improvement. As illustrated by this case study for a small molecule product, the appropriate use of established conditions can successfully narrow the technical and regulatory gaps that limited the realization of flexible regulatory approaches promised by the application of Quality by Design principles.
TECHNICAL: Lyophilizer Instrument Calibration: Principles and Practices Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. A greater understanding of the science and technology of lyophilization drives improvements in calibration, which leads to better process control and increased confidence in achieving product quality.